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Norco Comfortprene Long Wrist Wrap, Black, Large
EUDAMEDClass I (EU MDR)
Ref NC58600-3BKModel 1213
Identity
- Trade Name
- Norco Comfortprene Long Wrist Wrap, Black, Large EUDAMED
- Device Name
- Norco Long Wrist Wrap EUDAMED
- Model / Reference
- 1213 EUDAMEDNC58600-3BK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627008563 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-1213-MF EUDAMED
- Direct Marketing DI
- 00768627008563 EUDAMED
- EMDN Code
- Y060612 WRIST-HAND ORTHOSES 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
Norco Comfortprene Long Wrist Wrap, Black, Large 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 | 0768627ORTHO-1213-MF | 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 2a3c7f57-0d52-4ecd-8d19-85ca6ae08a40 61 fields · synced Jul 14, 2026