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Big-Grip
EUDAMEDClass I (EU MDR)
Ref NC65582Model 238Ref NC65585Ref NC65565Model 229Ref NC65561Ref NC65564Ref NC65590Ref NC65597Model 4200Ref NC65591
Identity
- Trade Name
- Big-Grip EUDAMED
- Device Name
- Big-Grip Standard Utensils EUDAMEDWeighted Fork EUDAMEDCoated Teaspoon EUDAMED
- Model / Reference
- 238 EUDAMEDNC65582 EUDAMEDNC65585 EUDAMED229 EUDAMEDNC65565 EUDAMEDNC65561 EUDAMEDNC65564 EUDAMEDNC65590 EUDAMED4200 EUDAMEDNC65597 EUDAMEDNC65591 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627013505 EUDAMED00768627655859 EUDAMED00768627655651 EUDAMED00768627655613 EUDAMED00768627655644 EUDAMED00768627655903 EUDAMED00768627655972 EUDAMED00768627655910 EUDAMED
- Basic UDI-DI
- 0768627REHAB-238-FC EUDAMED0768627REHAB-229-FA EUDAMED0768627REHAB-4200-RD EUDAMED
- Direct Marketing DI
- 00768627013505 EUDAMED00768627655859 EUDAMED00768627655651 EUDAMED00768627655613 EUDAMED00768627655644 EUDAMED00768627655903 EUDAMED00768627655972 EUDAMED00768627655910 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 (8)
- EUDAMED 9f8eb138-5dfd-406e-b34f-2a231710377c 61 fields · synced Aug 5, 2026
- EUDAMED f795a971-6b67-4ab1-9b4a-dd7ea33a606d 61 fields · synced May 16, 2026
- EUDAMED ee4f0a29-0845-4a21-b9e4-c13cbd8aae9c 61 fields · synced May 16, 2026
- EUDAMED 4f518748-a77b-46d3-a2d4-c182c4beb7e9 61 fields · synced May 17, 2026
- EUDAMED 3ce73c6b-446d-488d-b3b4-a179318c625a 61 fields · synced May 17, 2026
- EUDAMED eb60c2f9-2b9f-489f-b156-2e6940bd8c26 61 fields · synced May 17, 2026
- EUDAMED 294861b0-e5c4-4f55-a025-864b94f69a30 61 fields · synced May 17, 2026
- EUDAMED 8f2e7c40-ace0-4a9c-9e33-28071b51b207 61 fields · synced May 18, 2026