Identity
- Trade Name
- Omega; Black Perf. 1/8 18 x 24in (4) Thermoplastic EUDAMED
- Device Name
- Omega Black Thermoplastic EUDAMED
- Model / Reference
- 2690 EUDAMEDNC12798-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627014625 EUDAMED
- Basic UDI-DI
- 0768627CSTACC-2690-T9 EUDAMED
- Direct Marketing DI
- 00768627014625 EUDAMED
- EMDN Code
- M030504 IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPERATURES EUDAMED
- Models / Variants
- Omega 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
Omega - Omega by North Coast Medical, Inc. — Class I — MDR — listed in EUDAMED — 2 models — 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 (1)
- EUDAMED 2b52745f-4fbf-4654-92c5-9def67ddff66 61 fields · synced Jun 18, 2026