Identity
- Trade Name
- Big-Grip EUDAMED
- Device Name
- Big-Grip Standard Utensils EUDAMED
- Model / Reference
- 238 EUDAMEDNC65594 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627655941 EUDAMED
- Basic UDI-DI
- 0768627REHAB-238-FC EUDAMED
- Direct Marketing DI
- 00768627655941 EUDAMED
- EMDN Code
- Y150912 CUTLERY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Big-Grip 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 | 0768627REHAB-238-FC | 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 59485cd1-9c47-4a47-ab49-5bc57fa0edad 61 fields · synced Jun 19, 2026