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Encore
EUDAMEDClass I (EU MDR)
Ref NC14053-1BModel 985Ref NC14055-1KRef NC14052-1KRef NC14053-KRef NC14050-1BRef NC14051-1K
Identity
- Trade Name
- Encore EUDAMED
- Device Name
- Encore EUDAMED
- Model / Reference
- 985 EUDAMEDNC14053-1B EUDAMEDNC14055-1K EUDAMEDNC14052-1K EUDAMEDNC14053-K EUDAMEDNC14050-1B EUDAMEDNC14051-1K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627002943 EUDAMED00768627003094 EUDAMED00768627002905 EUDAMED00768627002998 EUDAMED00768627002745 EUDAMED00768627002837 EUDAMED
- Basic UDI-DI
- 0768627CSTACC-985-A6 EUDAMED
- Direct Marketing DI
- 00768627002943 EUDAMED00768627003094 EUDAMED00768627002905 EUDAMED00768627002998 EUDAMED00768627002745 EUDAMED00768627002837 EUDAMED
- EMDN Code
- M030504 IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPERATURES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Encore 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-985-A6 | 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 (6)
- EUDAMED 953ae04f-fe0d-4fa1-b914-81c3d6a9cd51 61 fields · synced Jul 25, 2026
- EUDAMED 6dde67e3-1e68-436c-a9ec-b1d6625b768e 61 fields · synced May 18, 2026
- EUDAMED c2d517c0-ff77-4ff1-a70a-88bf14958ade 61 fields · synced May 18, 2026
- EUDAMED e04302d5-128b-477c-9d38-16ff9a83c6ad 61 fields · synced May 18, 2026
- EUDAMED 6c0aa55a-f197-45b4-94b8-d15ee189e887 61 fields · synced May 18, 2026
- EUDAMED ff97fb17-a473-46ad-8ffa-0e6162983991 61 fields · synced May 19, 2026