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Omega Plus
EUDAMEDClass I (EU MDR)
Ref NC13311Model 1038Ref NC13310-1Ref NC13310
Identity
- Trade Name
- Omega Plus EUDAMED
- Device Name
- Omega Plus EUDAMED
- Model / Reference
- 1038 EUDAMEDNC13311 EUDAMEDNC13310-1 EUDAMEDNC13310 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10768627133118 EUDAMED00768627002608 EUDAMED00768627133104 EUDAMED
- Basic UDI-DI
- 0768627CSTACC-1038-RE EUDAMED
- Direct Marketing DI
- 10768627133118 EUDAMED00768627002608 EUDAMED00768627133104 EUDAMED
- EMDN Code
- M030504 IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPERATURES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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 Plus 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-1038-RE | 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 4b04c7ff-33c5-4684-9001-fa986977d364 61 fields · synced Jul 20, 2026
- EUDAMED 3d71bc25-05e7-495a-9be5-adab69f6f9e9 61 fields · synced May 18, 2026
- EUDAMED e06af133-2e71-4b96-abfe-7d347b56269e 61 fields · synced May 18, 2026