Drug Delivery & Combination Products: Component Categories

Pre-Filled Syringe Barrels

Key Specs: volume, COP/Type I glass, flange

Ready-to-use primary drug containers in borosilicate glass or cyclic olefin polymer with low extractables/leachables.

Supplier	Stated Capabilities & Technical Focus	Procurement
Gerresheimer Dusseldorf, Germany / Peachtree City, GA, USA	Type I borosilicate glass and Gx RTF cyclic olefin polymer (COP) prefillable syringe barrels FDA registered · FEI 3013445959	RFQ ›
Pre-Filled Syringe Barrels Gerresheimer — Pre-Filled Syringe Barrels Engineering Profile Type I borosilicate glass and Gx RTF cyclic olefin polymer (COP) prefillable syringe barrels Key Specs: volume, COP/Type I glass, flange Facility: Dusseldorf, Germany / Peachtree City, GA, USA Visit Gerresheimer website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “service partner for diagnostics and medical device.” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: syringes · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — not found No statement of current ISO 13485 certification was found on the pages read. “Working toward” or “planned” does not count. Closest wording found: “11, ISO 9001, ISO 13485, MDD 93/42/EEC, AMG/MPG/AMWHV.”, not counted (no certification wording bound to the mention). what was checked ↗ · checked 2026-10-20 FDA establishment registration — found Registered as Gerresheimer Peachtree City, L.P.: FEI 3013445959; Contract Manufacturer; Peachtree City, GA · FDA record ↗ · checked 2026-10-20
SCHOTT Pharma Mainz, Germany / Lebanon, PA, USA	syriQ glass pre-filled syringes and TOPPAC polymer prefillable COC syringes ISO 13485 stated on site	RFQ ›
Pre-Filled Syringe Barrels SCHOTT Pharma — Pre-Filled Syringe Barrels Engineering Profile syriQ glass pre-filled syringes and TOPPAC polymer prefillable COC syringes Key Specs: volume, COP/Type I glass, flange Facility: Mainz, Germany / Lebanon, PA, USA Visit SCHOTT Pharma website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “reusable and single-use medtech devices, SCHOTT offers” · source ↗ · checked 2026-10-20 Site names this capability — not found information only, not scored This category’s capability terms were not all found on the pages read. Looked for: “syringe…”. what was checked ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “are certified to ISO 9001:2015, ISO 13485:2016, ISO” · source ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: PA, DE. what was checked ↗ · checked 2026-10-20
Stevanato Group (Ompi) Piombino Dese, Italy / Fishers, IN, USA	EZ-fill ready-to-use glass syringe barrels with staked needle assembly ISO 13485 stated on site	RFQ ›
Pre-Filled Syringe Barrels Stevanato Group (Ompi) — Pre-Filled Syringe Barrels Engineering Profile EZ-fill ready-to-use glass syringe barrels with staked needle assembly Key Specs: volume, COP/Type I glass, flange Facility: Piombino Dese, Italy / Fishers, IN, USA Visit Stevanato Group (Ompi) website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “customer-specific point-of-care devices, in-vitro diagnostic consumables and” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: syringe-device · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “9001, ISO 15378, ISO 13485 certified quality management” · source ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: IN, IT. what was checked ↗ · checked 2026-10-20

Plungers & Elastomeric Seals

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Key Specs: fluoropolymer barrier, sub-viscosity

Barrier-coated bromobutyl/chlorobutyl elastomeric plungers ensuring container closure integrity without silicone oil migration.

Supplier	Stated Capabilities & Technical Focus	Procurement
Datwyler Pharma Solutions Altdorf, Switzerland / Pennsauken, NJ, USA	OmniFlex fluoropolymer spray-coated plunger stoppers for zero silicone oil drop	RFQ ›
Plungers & Elastomeric Seals Datwyler Pharma Solutions — Plungers & Elastomeric Seals Engineering Profile OmniFlex fluoropolymer spray-coated plunger stoppers for zero silicone oil drop Key Specs: fluoropolymer barrier, sub-viscosity Facility: Altdorf, Switzerland / Pennsauken, NJ, USA Visit Datwyler Pharma Solutions website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “rubber products for the Japanese medical market.” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: plungers · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — not found No statement of current ISO 13485 certification was found on the pages read. “Working toward” or “planned” does not count. (no ISO 13485 mention on 10 pages read) what was checked ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: NJ, CH. what was checked ↗ · checked 2026-10-20
Aptar Pharma Louveciennes, France / Crystal Lake, IL, USA	Premium elastomer formulations for prefilled syringe plungers and needle shields	RFQ ›
Plungers & Elastomeric Seals Aptar Pharma — Plungers & Elastomeric Seals Engineering Profile Premium elastomer formulations for prefilled syringe plungers and needle shields Key Specs: fluoropolymer barrier, sub-viscosity Facility: Louveciennes, France / Crystal Lake, IL, USA Visit Aptar Pharma website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — not found No statement that it serves medical devices or medical device makers was found on the pages read. (no medical-market phrase in page body on 10 pages read) what was checked ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: stoppers · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — not found No statement of current ISO 13485 certification was found on the pages read. “Working toward” or “planned” does not count. (no ISO 13485 mention on 10 pages read) what was checked ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: IL, FR. what was checked ↗ · checked 2026-10-20
West Pharmaceutical Services Exton, PA, USA / Eschweiler, Germany	NovaPure and FluroTec barrier-coated elastomeric stoppers and plunger seals	RFQ ›
Plungers & Elastomeric Seals West Pharmaceutical Services — Plungers & Elastomeric Seals Engineering Profile NovaPure and FluroTec barrier-coated elastomeric stoppers and plunger seals Key Specs: fluoropolymer barrier, sub-viscosity Facility: Exton, PA, USA / Eschweiler, Germany Visit West Pharmaceutical Services website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — not found No statement that it serves medical devices or medical device makers was found on the pages read. (no medical-market phrase in page body on 10 pages read) what was checked ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: stoppers · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — not found No statement of current ISO 13485 certification was found on the pages read. “Working toward” or “planned” does not count. (no ISO 13485 mention on 10 pages read) what was checked ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: PA, DE. what was checked ↗ · checked 2026-10-20

Hypodermic Tubing

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Key Specs: gauge, wall, temper

Stock stainless tubing by gauge and wall class — the raw material for cannulae and instrument shafts.

📐 Standard Stock Sizes & Scales

Medical Hypodermic Tubing Gauge Chart (ISO 9626 / ASTM A908)

ISO 9626:2016 / ASTM A908 (304V / 316L Full Hard)

Select Gauge & Wall Class:

Draft RFQ for Selected Size ›

OD: 0.203″ (5.156 mm) ID: 0.173″ (4.394 mm) Wall: 0.015″ (0.381 mm) Class: RW (Regular Wall) Target: Large trocar sleeves, cannula blanks

Toggle Complete Stock Size Table (53 sizes)

Gauge	Wall Class	Nominal OD (in)	Nominal OD (mm)	Nominal ID (in)	Nominal ID (mm)	Wall (in)	Wall (mm)	Application	Action
6 Gauge RW	RW (Regular Wall)	0.2030″	5.156	0.1730″	4.394	0.0150″	0.381	Large trocar sleeves, cannula blanks	RFQ ›
6 Gauge TW	TW (Thin Wall)	0.2030″	5.156	0.1810″	4.597	0.0110″	0.279	Aspiration cannulae, instrument housings	RFQ ›
8 Gauge RW	RW (Regular Wall)	0.1650″	4.191	0.1350″	3.429	0.0150″	0.381	Arthroscopic cannulae, bone access	RFQ ›
8 Gauge TW	TW (Thin Wall)	0.1650″	4.191	0.1470″	3.734	0.0090″	0.229	High-flow suction lines	RFQ ›
10 Gauge RW	RW (Regular Wall)	0.1340″	3.404	0.1060″	2.692	0.0140″	0.356	Biopsy needles, laparoscopic shafts	RFQ ›
10 Gauge TW	TW (Thin Wall)	0.1340″	3.404	0.1160″	2.946	0.0090″	0.229	Endoscopic guide shafts	RFQ ›
11 Gauge RW	RW (Regular Wall)	0.1200″	3.048	0.0940″	2.388	0.0130″	0.330	Bone marrow biopsy needles	RFQ ›
11 Gauge TW	TW (Thin Wall)	0.1200″	3.048	0.1020″	2.591	0.0090″	0.229	Vertebroplasty needles	RFQ ›
12 Gauge RW	RW (Regular Wall)	0.1090″	2.769	0.0850″	2.159	0.0120″	0.305	Veterinary / large animal access	RFQ ›
12 Gauge TW	TW (Thin Wall)	0.1090″	2.769	0.0930″	2.362	0.0080″	0.203	Large core tissue biopsy	RFQ ›
13 Gauge RW	RW (Regular Wall)	0.0950″	2.413	0.0710″	1.803	0.0120″	0.305	Vertebroplasty & kyphoplasty	RFQ ›
13 Gauge TW	TW (Thin Wall)	0.0950″	2.413	0.0810″	2.057	0.0070″	0.178	Blood transfusion cannulae	RFQ ›
14 Gauge RW	RW (Regular Wall)	0.0830″	2.108	0.0630″	1.600	0.0100″	0.254	Central venous catheter introducers	RFQ ›
14 Gauge TW	TW (Thin Wall)	0.0830″	2.108	0.0690″	1.753	0.0070″	0.178	Rapid fluid infusion catheters	RFQ ›
14 Gauge UTW	UTW (Ultra Thin Wall)	0.0830″	2.108	0.0730″	1.854	0.0050″	0.127	High-flow dialysis access	RFQ ›
15 Gauge RW	RW (Regular Wall)	0.0720″	1.829	0.0540″	1.372	0.0090″	0.229	Apheresis & blood bank needles	RFQ ›
15 Gauge TW	TW (Thin Wall)	0.0720″	1.829	0.0600″	1.524	0.0060″	0.152	Autologous blood collection	RFQ ›
16 Gauge RW	RW (Regular Wall)	0.0650″	1.651	0.0470″	1.194	0.0090″	0.229	Surgical drainage, large IV lines	RFQ ›
16 Gauge TW	TW (Thin Wall)	0.0650″	1.651	0.0530″	1.346	0.0060″	0.152	Trauma & resuscitation IV	RFQ ›
16 Gauge UTW	UTW (Ultra Thin Wall)	0.0650″	1.651	0.0570″	1.448	0.0040″	0.102	Thin-wall hypotube shaft proximal	RFQ ›
17 Gauge RW	RW (Regular Wall)	0.0580″	1.473	0.0420″	1.067	0.0080″	0.203	Epidural Tuohy needles	RFQ ›
17 Gauge TW	TW (Thin Wall)	0.0580″	1.473	0.0480″	1.219	0.0050″	0.127	Oocyte retrieval needles	RFQ ›
18 Gauge RW	RW (Regular Wall)	0.0500″	1.270	0.0330″	0.838	0.0085″	0.216	Standard blood drawing, medication prep	RFQ ›
18 Gauge TW	TW (Thin Wall)	0.0500″	1.270	0.0400″	1.016	0.0050″	0.127	Interventional access, Seldinger needle	RFQ ›
18 Gauge UTW	UTW (Ultra Thin Wall)	0.0500″	1.270	0.0430″	1.092	0.0035″	0.089	Catheter hypotube proximal shaft	RFQ ›
19 Gauge RW	RW (Regular Wall)	0.0420″	1.067	0.0270″	0.686	0.0075″	0.191	Parenteral medication filtration	RFQ ›
19 Gauge TW	TW (Thin Wall)	0.0420″	1.067	0.0320″	0.813	0.0050″	0.127	Fine aspiration needles	RFQ ›
20 Gauge RW	RW (Regular Wall)	0.0350″	0.889	0.0230″	0.584	0.0060″	0.152	Standard IV catheter, blood sampling	RFQ ›
20 Gauge TW	TW (Thin Wall)	0.0350″	0.889	0.0260″	0.660	0.0045″	0.114	Vascular access, 0.021″ wire guide	RFQ ›
20 Gauge UTW	UTW (Ultra Thin Wall)	0.0350″	0.889	0.0290″	0.737	0.0030″	0.076	Catheter micro-hypotube	RFQ ›
21 Gauge RW	RW (Regular Wall)	0.0320″	0.813	0.0200″	0.508	0.0060″	0.152	Diagnostic venipuncture, IM injection	RFQ ›
21 Gauge TW	TW (Thin Wall)	0.0320″	0.813	0.0230″	0.584	0.0045″	0.114	0.018″ guidewire micropuncture needle	RFQ ›
22 Gauge RW	RW (Regular Wall)	0.0280″	0.711	0.0160″	0.406	0.0060″	0.152	Standard pediatric & elderly IV	RFQ ›
22 Gauge TW	TW (Thin Wall)	0.0280″	0.711	0.0200″	0.508	0.0040″	0.102	Spinal anesthesia Quincke needle	RFQ ›
22 Gauge UTW	UTW (Ultra Thin Wall)	0.0280″	0.711	0.0220″	0.559	0.0030″	0.076	0.018″ guidewire introducer	RFQ ›
23 Gauge RW	RW (Regular Wall)	0.0250″	0.635	0.0130″	0.330	0.0060″	0.152	Small vein blood collection	RFQ ›
23 Gauge TW	TW (Thin Wall)	0.0250″	0.635	0.0170″	0.432	0.0040″	0.102	Vitreoretinal surgical cannula	RFQ ›
24 Gauge RW	RW (Regular Wall)	0.0220″	0.559	0.0120″	0.305	0.0050″	0.127	Neonatal & pediatric IV access	RFQ ›
25 Gauge RW	RW (Regular Wall)	0.0200″	0.508	0.0100″	0.254	0.0050″	0.127	Subcutaneous injection, vaccines	RFQ ›
25 Gauge TW	TW (Thin Wall)	0.0200″	0.508	0.0120″	0.305	0.0040″	0.102	Dental anesthesia, ophthalmic cannula	RFQ ›
25 Gauge UTW	UTW (Ultra Thin Wall)	0.0200″	0.508	0.0140″	0.356	0.0030″	0.076	Microcatheter distal reinforcement	RFQ ›
26 Gauge RW	RW (Regular Wall)	0.0180″	0.457	0.0090″	0.229	0.0045″	0.114	Intradermal skin testing	RFQ ›
27 Gauge RW	RW (Regular Wall)	0.0160″	0.406	0.0080″	0.203	0.0040″	0.102	Insulin injection, dental block	RFQ ›
27 Gauge TW	TW (Thin Wall)	0.0160″	0.406	0.0100″	0.254	0.0030″	0.076	Ophthalmic intravitreal injection	RFQ ›
27 Gauge UTW	UTW (Ultra Thin Wall)	0.0160″	0.406	0.0120″	0.305	0.0020″	0.051	Low-force aesthetic botox needle	RFQ ›
28 Gauge RW	RW (Regular Wall)	0.0140″	0.356	0.0070″	0.178	0.0035″	0.089	Micro-cannula cosmetic filler	RFQ ›
29 Gauge RW	RW (Regular Wall)	0.0130″	0.330	0.0070″	0.178	0.0030″	0.076	Insulin pen needles	RFQ ›
30 Gauge RW	RW (Regular Wall)	0.0120″	0.305	0.0060″	0.152	0.0030″	0.076	Fine dental anesthesia, capillary tubes	RFQ ›
30 Gauge TW	TW (Thin Wall)	0.0120″	0.305	0.0075″	0.191	0.0022″	0.057	Intraocular micro-injection	RFQ ›
31 Gauge RW	RW (Regular Wall)	0.0100″	0.254	0.0050″	0.127	0.0025″	0.064	Ultra-fine insulin pen tip	RFQ ›
32 Gauge RW	RW (Regular Wall)	0.0090″	0.229	0.0040″	0.102	0.0025″	0.064	Mesotherapy & aesthetic micro-injection	RFQ ›
33 Gauge RW	RW (Regular Wall)	0.0080″	0.203	0.0040″	0.102	0.0020″	0.051	Sub-retinal injection cannula	RFQ ›
34 Gauge RW	RW (Regular Wall)	0.0065″	0.165	0.0030″	0.076	0.0018″	0.045	Neuroscience micro-dialysis probes	RFQ ›

Supplier	Stated Capabilities & Technical Focus	Procurement
Alleima (formerly Sandvik) Hallstahammar, Sweden	Seamless stainless steel and cobalt-chromium medical tubing with strict ID finish ISO 13485 stated on site FDA registered · FEI 3007055279	RFQ ›
Hypodermic Tubing Alleima (formerly Sandvik) — Hypodermic Tubing Engineering Profile Seamless stainless steel and cobalt-chromium medical tubing with strict ID finish Key Specs: gauge, wall, temper Facility: Hallstahammar, Sweden Visit Alleima (formerly Sandvik) website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “fine medical wire specifically for medical devices.” · source ↗ · checked 2026-10-20 Site names this capability — not found information only, not scored This category’s capability terms were not all found on the pages read. Looked for: (“hypodermic” or “hypotube…”) and (“tubing” or “tube…”). Found: tubing. what was checked ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “ISO13485” · source ↗ · checked 2026-10-20 FDA establishment registration — found Registered as Alleima Karlsruhe GmbH: FEI 3007055279; Contract Manufacturer; Karlsruhe Baden-Wurttemberg, DE · FDA record ↗ · site named on company’s own page ↗ · checked 2026-10-20
Eagle Stainless Tube & Manufacturing Franklin, MA, USA	Precision 304/316 hypodermic tubing across all standard RW, TW, and XTW gauges ISO 13485 stated on site	RFQ ›
Hypodermic Tubing Eagle Stainless Tube & Manufacturing — Hypodermic Tubing Engineering Profile Precision 304/316 hypodermic tubing across all standard RW, TW, and XTW gauges Key Specs: gauge, wall, temper Facility: Franklin, MA, USA Visit Eagle Stainless Tube & Manufacturing website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “parts for the medical device industry, along” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: hypodermic, tubing · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “our certifications, including ISO 9001 and ISO 13485” · source ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: MA. what was checked ↗ · checked 2026-10-20
MicroGroup (TE Connectivity) Medway, MA, USA	Small-diameter hypodermic metal tube drawing, cutting, and CNC fabrication ISO 13485 stated on site	RFQ ›
Hypodermic Tubing MicroGroup (TE Connectivity) — Hypodermic Tubing Engineering Profile Small-diameter hypodermic metal tube drawing, cutting, and CNC fabrication Key Specs: gauge, wall, temper Facility: Medway, MA, USA Visit MicroGroup (TE Connectivity) website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “We offer Medical Device OEMs a broad” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: hypodermic, tubing · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “MicroGroup obtains ISO 13485 certification.” · source ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: MA. what was checked ↗ · checked 2026-10-20

Point Grinds

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Key Specs: lancet, back-bevel, trocar

Tip geometry ground onto a cannula. The grind type drives penetration force and tissue coring.

Supplier	Stated Capabilities & Technical Focus	Procurement
Cadence, Inc. Staunton, VA, USA	CNC lancet, Huber, back-bevel, and trocar needle point grinding with zero burr ISO 13485 stated on site FDA registered · FEI 3009266751	RFQ ›
Point Grinds Cadence, Inc. — Point Grinds Engineering Profile CNC lancet, Huber, back-bevel, and trocar needle point grinding with zero burr Key Specs: lancet, back-bevel, trocar Facility: Staunton, VA, USA Visit Cadence, Inc. website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “how a full-service medical device contract manufacturing” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: grinding, needles · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “System is certified to ISO 13485:2016 and compliant” · source ↗ · checked 2026-10-20 FDA establishment registration — found Registered as Cadence Inc.: FEI 3009266751; Contract Manufacturer; Staunton, VA · FDA record ↗ · checked 2026-10-20
Popper & Sons (Norwood Medical) Dayton, OH, USA	Custom surgical point grinding, stylets, biopsy bevel geometries ISO 13485 stated on site FDA registered · FEI 3002993297	RFQ ›
Point Grinds Popper & Sons (Norwood Medical) — Point Grinds Engineering Profile Custom surgical point grinding, stylets, biopsy bevel geometries Key Specs: lancet, back-bevel, trocar Facility: Dayton, OH, USA Visit Popper & Sons (Norwood Medical) website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “The most visionary medical device companies in” · source ↗ · checked 2026-10-20 Site names this capability — not found information only, not scored This category’s capability terms were not all found on the pages read. Looked for: (“grind…” or “bevel…”) and (“needle…” or “point…” or “cannula…” or “tip…”). Found: needles. what was checked ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “ISO 13485:2016” · source ↗ · checked 2026-10-20 FDA establishment registration — found Registered as NORWOOD MEDICAL LLC: FEI 3002993297; Contract Manufacturer; Dayton, OH · FDA record ↗ · checked 2026-10-20
Tegra Medical Franklin, MA, USA	High-speed rotary electrochemical and abrasive needle point grinding FDA registered · FEI 3002758924	RFQ ›
Point Grinds Tegra Medical — Point Grinds Engineering Profile High-speed rotary electrochemical and abrasive needle point grinding Key Specs: lancet, back-bevel, trocar Facility: Franklin, MA, USA Visit Tegra Medical website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “Is Your Medical Device Sharp Enough?” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: grinding, tips · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — not found No statement of current ISO 13485 certification was found on the pages read. “Working toward” or “planned” does not count. Closest wording found: “ISO 13485 and FDA QSR compliant.”, not counted (no certification wording bound to the mention). what was checked ↗ · checked 2026-10-20 FDA establishment registration — found Registered as Tegra Medical - Franklin, MA: FEI 3002758924; Contract Manufacturer; Franklin, MA · FDA record ↗ · checked 2026-10-20

MEMS Infusion Micropumps

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Key Specs: piezoelectric, nL/min dosing, check valves

Silicon micromachined diaphragm pumps delivering continuous basal and on-demand bolus micro-doses in wearable patch injectors.

Supplier	Stated Capabilities & Technical Focus	Procurement
Debiotech Lausanne, Switzerland	Silicon MEMS nanopumps for precise basal/bolus insulin delivery ISO 13485 stated on site	RFQ ›
MEMS Infusion Micropumps Debiotech — MEMS Infusion Micropumps Engineering Profile Silicon MEMS nanopumps for precise basal/bolus insulin delivery Key Specs: piezoelectric, nL/min dosing, check valves Facility: Lausanne, Switzerland Visit Debiotech website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “medical device development since 30+ years.” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: mems · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “Debiotech, ISO 13485 certified, provides” · source ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: CH. what was checked ↗ · checked 2026-10-20
Bartels Mikrotechnik Dortmund, Germany	Piezoelectric diaphragm micropumps for wearable drug delivery devices	RFQ ›
MEMS Infusion Micropumps Bartels Mikrotechnik — MEMS Infusion Micropumps Engineering Profile Piezoelectric diaphragm micropumps for wearable drug delivery devices Key Specs: piezoelectric, nL/min dosing, check valves Facility: Dortmund, Germany Visit Bartels Mikrotechnik website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “micropumps for biotechnology, pharmaceuticals, and medical technology.” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: micropumps · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — not found No statement of current ISO 13485 certification was found on the pages read. “Working toward” or “planned” does not count. (no ISO 13485 mention on 10 pages read) what was checked ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: DE. what was checked ↗ · checked 2026-10-20
Sensirion AG Stäfa, Switzerland	Silicon MEMS micropumps and liquid flow sensors for patch infusion	RFQ ›
MEMS Infusion Micropumps Sensirion AG — MEMS Infusion Micropumps Engineering Profile Silicon MEMS micropumps and liquid flow sensors for patch infusion Key Specs: piezoelectric, nL/min dosing, check valves Facility: Stäfa, Switzerland Visit Sensirion AG website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “In medical technology, our sensors provide a” · source ↗ · checked 2026-10-20 Site names this capability — not found information only, not scored This category’s capability terms were not all found on the pages read. Looked for: “micropump…” or “micro pump…” or “mems”. what was checked ↗ · checked 2026-10-20 Site states ISO 13485 certification — not found No statement of current ISO 13485 certification was found on the pages read. “Working toward” or “planned” does not count. (no ISO 13485 mention on 10 pages read) what was checked ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: CH. what was checked ↗ · checked 2026-10-20

Prefilled Borosilicate Glass Barrels

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Key Specs: Type 1 borosilicate, baked silicone, staked needle

Pharmaceutical primary container barrels with tightly controlled internal diameters, low tungsten extractables, and immobilized baked-on silicone lubrication.

Supplier	Stated Capabilities & Technical Focus	Evidence	Procurement
No suppliers listed for this category yet.

Barrier-Film Coated Plunger Stoppers

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Key Specs: FluroTec / Omniflex, halobutyl rubber, sub-visible particles

Bromobutyl or chlorobutyl elastomeric piston stoppers laminated with fluoropolymer barrier films to eliminate extractables and maintain container closure integrity.

Supplier	Stated Capabilities & Technical Focus	Evidence	Procurement
No suppliers listed for this category yet.

Rigid Needle Shields (RNS)

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Key Specs: polypropylene outer shell, elastomeric inner plug, sterile seal

Two-piece protective caps combining a rigid plastic external shell with a soft rubber inner seal to protect staked needle sharpness and maintain sterility.

Supplier	Stated Capabilities & Technical Focus	Evidence	Procurement
No suppliers listed for this category yet.

Dual-Chamber Reconstitution Cartridges

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Key Specs: lyo cake / diluent, center bypass channel, middle stopper

Specialized glass cylindrical barrels featuring a mid-barrel bypass bulge that allows sterile liquid diluent to mix with lyophilized powder immediately prior to injection.

Supplier	Stated Capabilities & Technical Focus	Evidence	Procurement
No suppliers listed for this category yet.

High-Force Power Springs

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Key Specs: spring rate, solid height, load

Tightly toleranced medical-grade power springs providing energy to trigger autoinjector needle insertion and delivery.

Supplier	Stated Capabilities & Technical Focus	Procurement
Lee Spring Brooklyn, NY, USA	Passivated medical stainless steel springs with custom force curves ISO 13485 stated on site	RFQ ›
High-Force Power Springs Lee Spring — High-Force Power Springs Engineering Profile Passivated medical stainless steel springs with custom force curves Key Specs: spring rate, solid height, load Facility: Brooklyn, NY, USA Visit Lee Spring website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “The medical and pharmaceutical industry requires stringent” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: spring · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “Lee Spring China Suzhou ISO 13485-2016 Certificate” · source ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: NY. what was checked ↗ · checked 2026-10-20
MW Components (Century Spring) Los Angeles, CA, USA	High-energy compression power springs for autoinjector viscous drug release ISO 13485 stated on site	RFQ ›
High-Force Power Springs MW Components (Century Spring) — High-Force Power Springs Engineering Profile High-energy compression power springs for autoinjector viscous drug release Key Specs: spring rate, solid height, load Facility: Los Angeles, CA, USA Visit MW Components (Century Spring) website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “MW Components offers medical manufacturing capabilities that” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: springs · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “ISO 13485” · source ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: CA. what was checked ↗ · checked 2026-10-20
Scherdel Medtec Marktredwitz, Germany	Precision valve and autoinjector drive springs with strict load-loss validation ISO 13485 stated on site	RFQ ›
High-Force Power Springs Scherdel Medtec — High-Force Power Springs Engineering Profile Precision valve and autoinjector drive springs with strict load-loss validation Key Specs: spring rate, solid height, load Facility: Marktredwitz, Germany Visit Scherdel Medtec website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “as a development partner in medical technology.” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: springs · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “ISO 13485” · source ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: DE. what was checked ↗ · checked 2026-10-20

Dose Engines & Lockouts

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Key Specs: dose volume, lockout, feedback

Precision molded mechanical dose dialers, needle safety shields, and end-of-injection audible feedback mechanisms.

Supplier	Stated Capabilities & Technical Focus	Procurement
Phillips-Medisize (Molex) Hudson, WI, USA / Kontiolahti, Finland	High-volume contract manufacturing of autoinjector bodies, gears, and needle shields ISO 13485 stated on site FDA registered · FEI 3004058281	RFQ ›
Dose Engines & Lockouts Phillips-Medisize (Molex) — Dose Engines & Lockouts Engineering Profile High-volume contract manufacturing of autoinjector bodies, gears, and needle shields Key Specs: dose volume, lockout, feedback Facility: Hudson, WI, USA / Kontiolahti, Finland Visit Phillips-Medisize (Molex) website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “world’s leading pharmaceutical, medtech and in vitro” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: injector · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “Quality Management System (QMS) certified to ISO 13485.” · source ↗ · checked 2026-10-20 FDA establishment registration — found Registered as PHILLIPS-MEDISIZE, LLC: FEI 3004058281; Contract Manufacturer; New Richmond, WI · FDA record ↗ · checked 2026-10-20
SHL Medical Zug, Switzerland / Taoyuan, Taiwan	Molly platform autoinjectors, modular automated assembly, integrated dose indicators ISO 13485 stated on site	RFQ ›
Dose Engines & Lockouts SHL Medical — Dose Engines & Lockouts Engineering Profile Molly platform autoinjectors, modular automated assembly, integrated dose indicators Key Specs: dose volume, lockout, feedback Facility: Zug, Switzerland / Taoyuan, Taiwan Visit SHL Medical website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — not found No statement that it serves medical devices or medical device makers was found on the pages read. (no medical-market phrase in page body on 10 pages read) what was checked ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: injectors · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “Medical Assembly & Services LLC ISO 13485 certificate” · source ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: CH, TW. what was checked ↗ · checked 2026-10-20
Ypsomed Delivery Systems Burgdorf, Switzerland	Custom & platform autoinjectors (UnoPen, YpsoMate), dose dials, and mechanical lockouts	RFQ ›
Dose Engines & Lockouts Ypsomed Delivery Systems — Dose Engines & Lockouts Engineering Profile Custom & platform autoinjectors (UnoPen, YpsoMate), dose dials, and mechanical lockouts Key Specs: dose volume, lockout, feedback Facility: Burgdorf, Switzerland Visit Ypsomed Delivery Systems website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “combination products and our own medical devices.” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: injectors · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — not found No statement of current ISO 13485 certification was found on the pages read. “Working toward” or “planned” does not count. Closest wording found: “It complies with ISO 13485:2016, EU Medical Device”, not counted (qualified: "complies"). what was checked ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: CH. what was checked ↗ · checked 2026-10-20

Biologic Autoinjector Springs

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Key Specs: spring force 20–80N, high-viscosity, fatigue

Custom high-tensile power springs delivering controlled linear force to discharge high-viscosity monoclonal antibodies in < 10 seconds.

Supplier	Stated Capabilities & Technical Focus	Procurement
Lee Spring Brooklyn, NY, USA	Precision medical-grade power springs with validated cycle-life testing ISO 13485 stated on site	RFQ ›
Biologic Autoinjector Springs Lee Spring — Biologic Autoinjector Springs Engineering Profile Precision medical-grade power springs with validated cycle-life testing Key Specs: spring force 20–80N, high-viscosity, fatigue Facility: Brooklyn, NY, USA Visit Lee Spring website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “The medical and pharmaceutical industry requires stringent” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: spring · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “Lee Spring China Suzhou ISO 13485-2016 Certificate” · source ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: NY. what was checked ↗ · checked 2026-10-20
MW Components Charlotte, NC, USA	Custom high-stress compression springs for biologic autoinjectors ISO 13485 stated on site	RFQ ›
Biologic Autoinjector Springs MW Components — Biologic Autoinjector Springs Engineering Profile Custom high-stress compression springs for biologic autoinjectors Key Specs: spring force 20–80N, high-viscosity, fatigue Facility: Charlotte, NC, USA Visit MW Components website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “MW Components offers medical manufacturing capabilities that” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: springs · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “ISO 13485” · source ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: CA. what was checked ↗ · checked 2026-10-20
Associated Spring (Barnes Group) Bristol, CT, USA	High-energy constant force and compression springs for drug delivery	RFQ ›
Biologic Autoinjector Springs Associated Spring (Barnes Group) — Biologic Autoinjector Springs Engineering Profile High-energy constant force and compression springs for drug delivery Key Specs: spring force 20–80N, high-viscosity, fatigue Facility: Bristol, CT, USA Visit Associated Spring (Barnes Group) website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — not checked timeout after 12 s. Could not be checked, so it counts neither way. Site says it serves medical devices — not checked site not read (timeout after 12 s). Could not be checked, so it counts neither way. Site names this capability — not checked information only, not scored site not read (timeout after 12 s). Could not be checked, so it counts neither way. Site states ISO 13485 certification — not checked site not read (timeout after 12 s). Could not be checked, so it counts neither way. FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: CT. what was checked ↗ · checked 2026-10-20

Dose Dialers & Leadscrews

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Key Specs: unit increments, non-reversing, audible click

Precision injection-molded dial selectors, leadscrews, and ratchet clutches delivering exact insulin and GLP-1 unit doses.

Supplier	Stated Capabilities & Technical Focus	Procurement
Phillips-Medisize Hudson, WI, USA	Multi-cavity precision molding of dial selectors, ratchet clutches, and leadscrews ISO 13485 stated on site FDA registered · FEI 3004058281	RFQ ›
Dose Dialers & Leadscrews Phillips-Medisize — Dose Dialers & Leadscrews Engineering Profile Multi-cavity precision molding of dial selectors, ratchet clutches, and leadscrews Key Specs: unit increments, non-reversing, audible click Facility: Hudson, WI, USA Visit Phillips-Medisize website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “world’s leading pharmaceutical, medtech and in vitro” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: pen injector · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “Quality Management System (QMS) certified to ISO 13485.” · source ↗ · checked 2026-10-20 FDA establishment registration — found Registered as PHILLIPS-MEDISIZE, LLC: FEI 3004058281; Contract Manufacturer; New Richmond, WI · FDA record ↗ · checked 2026-10-20
Gerresheimer Medical Systems Peachtree City, GA, USA / Bünde, Germany	Engineered mechanical drive engines for reusable and disposable pens FDA registered · FEI 3013445959	RFQ ›
Dose Dialers & Leadscrews Gerresheimer Medical Systems — Dose Dialers & Leadscrews Engineering Profile Engineered mechanical drive engines for reusable and disposable pens Key Specs: unit increments, non-reversing, audible click Facility: Peachtree City, GA, USA / Bünde, Germany Visit Gerresheimer Medical Systems website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “service partner for diagnostics and medical device.” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: pen injectors · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — not found No statement of current ISO 13485 certification was found on the pages read. “Working toward” or “planned” does not count. Closest wording found: “11, ISO 9001, ISO 13485, MDD 93/42/EEC, AMG/MPG/AMWHV.”, not counted (no certification wording bound to the mention). what was checked ↗ · checked 2026-10-20 FDA establishment registration — found Registered as Gerresheimer Peachtree City, L.P.: FEI 3013445959; Contract Manufacturer; Peachtree City, GA · FDA record ↗ · checked 2026-10-20
Nypro Healthcare (Jabil) Clinton, MA, USA	Micro-molding and automated assembly of clicking dose adjustment dials FDA registered · FEI 3011024991	RFQ ›
Dose Dialers & Leadscrews Nypro Healthcare (Jabil) — Dose Dialers & Leadscrews Engineering Profile Micro-molding and automated assembly of clicking dose adjustment dials Key Specs: unit increments, non-reversing, audible click Facility: Clinton, MA, USA Visit Nypro Healthcare (Jabil) website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “calls to improve medical device sustainability metrics” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: injectors · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — not found No statement of current ISO 13485 certification was found on the pages read. “Working toward” or “planned” does not count. Closest wording found: “ISO 13485”, not counted (no certification wording bound to the mention). what was checked ↗ · checked 2026-10-20 FDA establishment registration — found Registered as Nypro Inc (Maple Grove): FEI 3011024991; Contract Manufacturer; Maple Grove, MN · FDA record ↗ · site named on company’s own page ↗ · checked 2026-10-20

Geneva Mechanism Dose Display Wheels

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Key Specs: incremental indexing, anti-reverse ratchet, window display

Precision molded indexing count drums driven by non-reversing ratchets that register and track remaining doses in multi-dose pen injectors and dry powder inhalers.

Supplier	Stated Capabilities & Technical Focus	Evidence	Procurement
No suppliers listed for this category yet.

Micro-Dispensing Elastomeric Diaphragms

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Key Specs: liquid silicone rubber (LSR), micro-liter stroke, check valve

Micro-molded silicone pumping membranes that flex under piezoelectric or motor actuation to meter microliter drug volumes with repeatable CV <2%.

Supplier	Stated Capabilities & Technical Focus	Evidence	Procurement
No suppliers listed for this category yet.

Machined Components

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Key Specs: material, tolerance

Turned and milled parts — the general class that covers most reusable-instrument hardware.

Supplier	Stated Capabilities & Technical Focus	Procurement
Norman Noble Highland Heights, OH, USA	Micromachining, Swiss turning, milling for implants and surgical instruments FDA registered · FEI 3002755653	RFQ ›
Machined Components Norman Noble — Machined Components Engineering Profile Micromachining, Swiss turning, milling for implants and surgical instruments Key Specs: material, tolerance Facility: Highland Heights, OH, USA Visit Norman Noble website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — not checked no readable page text (content needs JavaScript). Could not be checked, so it counts neither way. Site names this capability — not checked information only, not scored no readable page text (content needs JavaScript). Could not be checked, so it counts neither way. Site states ISO 13485 certification — not checked no readable page text (content needs JavaScript). Could not be checked, so it counts neither way. FDA establishment registration — found Registered as NORMAN NOBLE, INC.: FEI 3002755653; Contract Manufacturer; Highland Heights, OH · FDA record ↗ · checked 2026-10-20
ARCH Medical Solutions archgp.com Website did not answer as this company on 2026-10-20 Bloomsburg, PA, USA	High-tolerance CNC machining of titanium, 17-4PH stainless, and PEEK components FDA registered · FEI 3006791286	RFQ ›
Machined Components ARCH Medical Solutions — Machined Components Engineering Profile High-tolerance CNC machining of titanium, 17-4PH stainless, and PEEK components Key Specs: material, tolerance Facility: Bloomsburg, PA, USA archgp.com Website did not answer as this company on 2026-10-20 DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — no answer The listed website did not return this company’s own page on the check date. (TLS error (ERR_TLS_CERT_ALTNAME_INVALID); plain http:// answers and redirects to archglobalprecision.com) archgp.com, not linked · checked 2026-10-20 Site says it serves medical devices — not checked site not read (TLS error (ERR_TLS_CERT_ALTNAME_INVALID); plain http:// answers and redirects to archglobalprecision.com). Could not be checked, so it counts neither way. Site names this capability — not checked information only, not scored site not read (TLS error (ERR_TLS_CERT_ALTNAME_INVALID); plain http:// answers and redirects to archglobalprecision.com). Could not be checked, so it counts neither way. Site states ISO 13485 certification — not checked site not read (TLS error (ERR_TLS_CERT_ALTNAME_INVALID); plain http:// answers and redirects to archglobalprecision.com). Could not be checked, so it counts neither way. FDA establishment registration — found Registered as ARCH MEDICAL SOLUTIONS - PHILADELPHIA, LLC DBA JADE PRECISION MEDICAL COMPONENTS: FEI 3006791286; Contract Manufacturer; Huntingdon Valley, PA · FDA record ↗ · checked 2026-10-20
Paragon Medical Pierceton, IN, USA	Complex metal and polymer machined assemblies for surgical and robotic tools FDA registered · FEI 3001814066	RFQ ›
Machined Components Paragon Medical — Machined Components Engineering Profile Complex metal and polymer machined assemblies for surgical and robotic tools Key Specs: material, tolerance Facility: Pierceton, IN, USA Visit Paragon Medical website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — not checked blocked automated access (HTTP 429). Could not be checked, so it counts neither way. Site says it serves medical devices — not checked site not read (blocked automated access (HTTP 429)). Could not be checked, so it counts neither way. Site names this capability — not checked information only, not scored site not read (blocked automated access (HTTP 429)). Could not be checked, so it counts neither way. Site states ISO 13485 certification — not checked site not read (blocked automated access (HTTP 429)). Could not be checked, so it counts neither way. FDA establishment registration — found Registered as Paragon Medical Inc.: FEI 3001814066; Contract Manufacturer; Castleton, IN · FDA record ↗ · checked 2026-10-20

Seals & O-Rings

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Key Specs: ID, wall, material

Elastomeric seals. ID versus OD versus wall is the classic ordering mistake, which is why they carry glyphs.

Supplier	Stated Capabilities & Technical Focus	Procurement
Apple Rubber Products Lancaster, NY, USA	Microminiature O-rings in medical-grade silicone, FKM, EPDM	RFQ ›
Seals & O-Rings Apple Rubber Products — Seals & O-Rings Engineering Profile Microminiature O-rings in medical-grade silicone, FKM, EPDM Key Specs: ID, wall, material Facility: Lancaster, NY, USA Visit Apple Rubber Products website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “Safety: Ensures that medical devices function as” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: seal · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — not found No statement of current ISO 13485 certification was found on the pages read. “Working toward” or “planned” does not count. (no ISO 13485 mention on 10 pages read) what was checked ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: NY. what was checked ↗ · checked 2026-10-20
Bal Seal Engineering Foothill Ranch, CA, USA	Spring-energized PTFE seals for low friction, sterilizable fluid handles	RFQ ›
Seals & O-Rings Bal Seal Engineering — Seals & O-Rings Engineering Profile Spring-energized PTFE seals for low friction, sterilizable fluid handles Key Specs: ID, wall, material Facility: Foothill Ranch, CA, USA Visit Bal Seal Engineering website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “protects millions of medical devices and critical” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: seal · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — not found No statement of current ISO 13485 certification was found on the pages read. “Working toward” or “planned” does not count. (no ISO 13485 mention on 10 pages read) what was checked ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: CA. what was checked ↗ · checked 2026-10-20
Trelleborg Sealing Solutions Fort Wayne, IN, USA / Stuttgart, Germany	Liquid silicone rubber (LSR) injection molded seals and Class VI O-rings	RFQ ›
Seals & O-Rings Trelleborg Sealing Solutions — Seals & O-Rings Engineering Profile Liquid silicone rubber (LSR) injection molded seals and Class VI O-rings Key Specs: ID, wall, material Facility: Fort Wayne, IN, USA / Stuttgart, Germany Visit Trelleborg Sealing Solutions website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “solutions for demanding medical device, biotech and” · source ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: seals · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — not found No statement of current ISO 13485 certification was found on the pages read. “Working toward” or “planned” does not count. (no ISO 13485 mention on 11 pages read) what was checked ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: IN, DE. what was checked ↗ · checked 2026-10-20

Passive Needle Safety Shields

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Key Specs: ISO 23908, lockout mechanism, clear view

Spring-driven telescoping safety sleeves that automatically extend and irreversibly lock over the cannula after autoinjector use.

Supplier	Stated Capabilities & Technical Focus	Procurement
Phillips-Medisize Hudson, WI, USA	High-volume cleanroom molding of anti-needlestick passive safety shields ISO 13485 stated on site FDA registered · FEI 3004058281	RFQ ›
Passive Needle Safety Shields Phillips-Medisize — Passive Needle Safety Shields Engineering Profile High-volume cleanroom molding of anti-needlestick passive safety shields Key Specs: ISO 23908, lockout mechanism, clear view Facility: Hudson, WI, USA Visit Phillips-Medisize website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “world’s leading pharmaceutical, medtech and in vitro” · source ↗ · checked 2026-10-20 Site names this capability — not found information only, not scored This category’s capability terms were not all found on the pages read. Looked for: “needle…” and (“safety” or “shield…”). what was checked ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “Quality Management System (QMS) certified to ISO 13485.” · source ↗ · checked 2026-10-20 FDA establishment registration — found Registered as PHILLIPS-MEDISIZE, LLC: FEI 3004058281; Contract Manufacturer; New Richmond, WI · FDA record ↗ · checked 2026-10-20
Rosti Medical Malmö, Sweden / Germantown, WI, USA	Precision automated assembly of autoinjector telescoping shields ISO 13485 stated on site	RFQ ›
Passive Needle Safety Shields Rosti Medical — Passive Needle Safety Shields Engineering Profile Precision automated assembly of autoinjector telescoping shields Key Specs: ISO 23908, lockout mechanism, clear view Facility: Malmö, Sweden / Germantown, WI, USA Visit Rosti Medical website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — found “Group to attend Medical Manufacturing Asia 2026” · source ↗ · checked 2026-10-20 Site names this capability — not found information only, not scored This category’s capability terms were not all found on the pages read. Looked for: “needle…” and (“safety” or “shield…”). Found: safety. what was checked ↗ · checked 2026-10-20 Site states ISO 13485 certification — found “ISO 13485” · source ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: WI, SE. what was checked ↗ · checked 2026-10-20
West Pharmaceutical Services Exton, PA, USA	Integrated safety systems and passive needle guard assemblies	RFQ ›
Passive Needle Safety Shields West Pharmaceutical Services — Passive Needle Safety Shields Engineering Profile Integrated safety systems and passive needle guard assemblies Key Specs: ISO 23908, lockout mechanism, clear view Facility: Exton, PA, USA Visit West Pharmaceutical Services website DRAFT RFQ SPECIFICATION › Attach 2D drawings (.dwg, .pdf) or 3D CAD (.step) to the RFQ. Evidence How evidence ratings work Website answers — yes HTTP 200 · source ↗ · checked 2026-10-20 Site says it serves medical devices — not found No statement that it serves medical devices or medical device makers was found on the pages read. (no medical-market phrase in page body on 10 pages read) what was checked ↗ · checked 2026-10-20 Site names this capability — found information only, not scored Matched: needle-free-transfer-device, safety · source ↗ · checked 2026-10-20 Site states ISO 13485 certification — not found No statement of current ISO 13485 certification was found on the pages read. “Working toward” or “planned” does not count. (no ISO 13485 mention on 10 pages read) what was checked ↗ · checked 2026-10-20 FDA establishment registration — not found No active openFDA registration matched this listing by name and location. That is common and expected for component makers, which are generally exempt (21 CFR 807.65(a)), and it says nothing about sites elsewhere. Locations searched: PA, DE. what was checked ↗ · checked 2026-10-20

Subcutaneous Soft Infusion Cannulas

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Key Specs: FEP / PTFE 24G–27G, steel introducer needle, 90° septum

Flexible polymer micro-cannulas deployed under the dermis by temporary piercing needles to deliver continuous basal and bolus insulin from wearable pumps.

Supplier	Stated Capabilities & Technical Focus	Evidence	Procurement
No suppliers listed for this category yet.

Dissolvable Polymeric Microneedle Arrays

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Key Specs: PVA / PVP matrix, 500µm height, painless stratum corneum

Micro-molded dissolvable polysaccharide or synthetic polymer needle arrays encapsulating biologics or vaccines that dissolve within minutes of skin insertion.

Supplier	Stated Capabilities & Technical Focus	Evidence	Procurement
No suppliers listed for this category yet.

Primary Container & Fluid Path

Actuation & Power Engine

Enclosure & User Interface

Component Catalog & Supplier Offerings

Gerresheimer — Pre-Filled Syringe Barrels Engineering Profile

SCHOTT Pharma — Pre-Filled Syringe Barrels Engineering Profile

Stevanato Group (Ompi) — Pre-Filled Syringe Barrels Engineering Profile

Datwyler Pharma Solutions — Plungers & Elastomeric Seals Engineering Profile

Aptar Pharma — Plungers & Elastomeric Seals Engineering Profile

West Pharmaceutical Services — Plungers & Elastomeric Seals Engineering Profile

Medical Hypodermic Tubing Gauge Chart (ISO 9626 / ASTM A908)

Alleima (formerly Sandvik) — Hypodermic Tubing Engineering Profile

Eagle Stainless Tube & Manufacturing — Hypodermic Tubing Engineering Profile

MicroGroup (TE Connectivity) — Hypodermic Tubing Engineering Profile

Cadence, Inc. — Point Grinds Engineering Profile

Popper & Sons (Norwood Medical) — Point Grinds Engineering Profile

Tegra Medical — Point Grinds Engineering Profile

Debiotech — MEMS Infusion Micropumps Engineering Profile

Bartels Mikrotechnik — MEMS Infusion Micropumps Engineering Profile

Sensirion AG — MEMS Infusion Micropumps Engineering Profile

Lee Spring — High-Force Power Springs Engineering Profile

MW Components (Century Spring) — High-Force Power Springs Engineering Profile

Scherdel Medtec — High-Force Power Springs Engineering Profile

Phillips-Medisize (Molex) — Dose Engines & Lockouts Engineering Profile

SHL Medical — Dose Engines & Lockouts Engineering Profile

Ypsomed Delivery Systems — Dose Engines & Lockouts Engineering Profile

Lee Spring — Biologic Autoinjector Springs Engineering Profile

MW Components — Biologic Autoinjector Springs Engineering Profile

Associated Spring (Barnes Group) — Biologic Autoinjector Springs Engineering Profile

Phillips-Medisize — Dose Dialers & Leadscrews Engineering Profile

Gerresheimer Medical Systems — Dose Dialers & Leadscrews Engineering Profile

Nypro Healthcare (Jabil) — Dose Dialers & Leadscrews Engineering Profile

Norman Noble — Machined Components Engineering Profile

ARCH Medical Solutions — Machined Components Engineering Profile

Paragon Medical — Machined Components Engineering Profile

Apple Rubber Products — Seals & O-Rings Engineering Profile

Bal Seal Engineering — Seals & O-Rings Engineering Profile

Trelleborg Sealing Solutions — Seals & O-Rings Engineering Profile

Phillips-Medisize — Passive Needle Safety Shields Engineering Profile

Rosti Medical — Passive Needle Safety Shields Engineering Profile

West Pharmaceutical Services — Passive Needle Safety Shields Engineering Profile