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Preferred
EUDAMEDClass I (EU MDR)
Ref NC12983Model 1002Ref NC12792Ref NC12791Ref NC12790Ref NC12790-1Ref NC12984-1Ref NC12983-1
Identity
- Trade Name
- Preferred EUDAMED
- Device Name
- Preferred EUDAMED
- Model / Reference
- 1002 EUDAMEDNC12983 EUDAMEDNC12792 EUDAMEDNC12791 EUDAMEDNC12790 EUDAMEDNC12790-1 EUDAMEDNC12984-1 EUDAMEDNC12983-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627129831 EUDAMED10768627127926 EUDAMED10768627127919 EUDAMED00768627127905 EUDAMED10768627002100 EUDAMED10768627002551 EUDAMED10768627002520 EUDAMED
- Basic UDI-DI
- 0768627CSTACC-1002-QD EUDAMED
- Direct Marketing DI
- 00768627129831 EUDAMED10768627127926 EUDAMED10768627127919 EUDAMED00768627127905 EUDAMED10768627002100 EUDAMED10768627002551 EUDAMED10768627002520 EUDAMED
- EMDN Code
- M030504 IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPERATURES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Preferred 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-1002-QD | 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 (7)
- EUDAMED 87b4a9f1-ccbb-4f75-9271-8a9d566aec7e 61 fields · synced Jul 30, 2026
- EUDAMED 107730df-7250-4be5-9e85-95ab13ad838b 61 fields · synced May 17, 2026
- EUDAMED 2c67ccca-e23b-431c-949d-d7ccc001df6a 61 fields · synced May 18, 2026
- EUDAMED b49b0124-88de-4389-a166-b5c3369ca58e 61 fields · synced May 18, 2026
- EUDAMED 5b0c3fee-77ec-4390-a76b-53c4fec5e18d 61 fields · synced May 18, 2026
- EUDAMED eb3e2888-5823-4008-b573-319b96032bef 61 fields · synced May 18, 2026
- EUDAMED cb6e42c8-391e-4456-be7d-86cb2a39e217 61 fields · synced May 19, 2026