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Omega Black Thermoplastic
EUDAMEDClass I (EU MDR)
Ref NC13301-1BModel 2690Ref NC13300-1BRef NC12796-1BRef NC12798-1BRef NC13300-4B
Identity
- Trade Name
- Omega Black Thermoplastic EUDAMEDOmega Black Thermoplastic 3/32 Smooth, 24 x 36 (2) EUDAMED
- Device Name
- Omega Black Thermoplastic EUDAMED
- Model / Reference
- 2690 EUDAMEDNC13301-1B EUDAMEDNC13300-1B EUDAMEDNC12796-1B EUDAMEDNC12798-1B EUDAMEDNC13300-4B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627008822 EUDAMED00768627008815 EUDAMED00768627008792 EUDAMED00768627008808 EUDAMED10768627006894 EUDAMED
- Basic UDI-DI
- 0768627CSTACC-2690-T9 EUDAMED
- Direct Marketing DI
- 00768627008822 EUDAMED00768627008815 EUDAMED00768627008792 EUDAMED00768627008808 EUDAMED10768627006894 EUDAMED
- EMDN Code
- M030504 IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPERATURES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden EUDAMEDFrance 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
Omega Black Thermoplastic 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-2690-T9 | 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 (5)
- EUDAMED 5e496ca4-e741-41d6-8c48-23d10a6ac273 61 fields · synced Jul 19, 2026
- EUDAMED ac2ec94f-97ae-44b3-b122-f5b6a84d9f2e 61 fields · synced May 17, 2026
- EUDAMED ab79d676-3408-403e-8f5b-bd4ce7464271 61 fields · synced May 17, 2026
- EUDAMED 6bdcc442-4b71-4cb5-9335-6829f2ca2c44 61 fields · synced May 17, 2026
- EUDAMED bb95208d-20e8-46d8-a984-05a109cf9841 61 fields · synced May 17, 2026