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Norco Comfortprene Splinting Material
EUDAMEDClass I (EU MDR)
Ref NC68008Model 854Ref NC68004Ref NC68000
Identity
- Trade Name
- Norco Comfortprene Splinting Material EUDAMED
- Device Name
- Comfortprene Splinting Material EUDAMED
- Model / Reference
- 854 EUDAMEDNC68008 EUDAMEDNC68004 EUDAMEDNC68000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627010047 EUDAMED00768627680042 EUDAMED00768627009980 EUDAMED
- Basic UDI-DI
- 0768627CSTACC-854-9D EUDAMED
- Direct Marketing DI
- 00768627010047 EUDAMED00768627680042 EUDAMED00768627009980 EUDAMED
- EMDN Code
- M030504 IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPERATURES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Norco Comfortprene Splinting Material 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-854-9D | 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 (3)
- EUDAMED 6afc87a4-a85c-4c27-aec7-3c58a375b41d 61 fields · synced Jul 27, 2026
- EUDAMED 9c720c22-8295-4522-a64f-b09b79589571 61 fields · synced May 18, 2026
- EUDAMED a80c3ab8-0f1e-4520-b5cf-2b6853ee52b6 61 fields · synced May 19, 2026