Identity
- Trade Name
- Encore Blue 1/8 18 x 24 in (4) EUDAMED
- Device Name
- Encore EUDAMED
- Model / Reference
- 985 EUDAMEDNC14050-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627002776 EUDAMED
- Basic UDI-DI
- 0768627CSTACC-985-A6 EUDAMED
- EMDN Code
- M030504 IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPERATURES 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
Encore Blue 1/8 18 x 24 in (4) 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 (1)
- EUDAMED 49bd6638-c12f-429a-b544-04a5b9bc2951 61 fields · synced Jul 9, 2026