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Norco Comfortprene, Perf. Beige Splinting Material, 1/16 in
EUDAMEDClass I (EU MDR)
Ref NC68006Model 854
Identity
- Trade Name
- Norco Comfortprene, Perf. Beige Splinting Material, 1/16 in EUDAMED
- Device Name
- Comfortprene Splinting Material EUDAMED
- Model / Reference
- 854 EUDAMEDNC68006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627010030 EUDAMED
- Basic UDI-DI
- 0768627CSTACC-854-9D EUDAMED
- Direct Marketing DI
- 00768627010030 EUDAMED
- EMDN Code
- M030504 IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPERATURES EUDAMED
Classification
- Device Class
- Class I 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, Perf. Beige Splinting Material, 1/16 in 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 (1)
- EUDAMED 59f311ae-fde7-4cb0-a950-a212ab923950 61 fields · synced Jun 19, 2026