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Preformed Functional Position Hand Splint 1/8"
EUDAMEDClass I (EU MDR)
Ref NC13531Model 635
Identity
- Trade Name
- Preformed Functional Position Hand Splint 1/8" EUDAMED
- Device Name
- Preformed Functional Position Hand Splint 1/8" EUDAMED
- Model / Reference
- 635 EUDAMEDNC13531 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627009362 EUDAMED
- Basic UDI-DI
- 0768627CSTACC-635-8Q EUDAMED
- Direct Marketing DI
- 00768627009362 EUDAMED
- EMDN Code
- M030504 IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPERATURES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Preformed Functional Position Hand Splint 1/8" by North Coast Medical, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0768627CSTACC-635-8Q | Class I | Active |
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Manufacturer
- Manufacturer
- North Coast Medical Inc.
- EUDAMED SRN
- US-MF-000009087
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (1)
- EUDAMED 85622c0f-00dd-4cab-8c08-b66e64cdb4ff 61 fields · synced Jun 19, 2026