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Comfort Cool D-Ring Thumb/Wrist, LXL Wristv Orthosis
EUDAMEDClass I (EU MDR)
Ref NC91258Model 68
Identity
- Trade Name
- Comfort Cool D-Ring Thumb/Wrist, LXL Wristv Orthosis EUDAMED
- Device Name
- Comfort Cool D-Ring Thumb Wrist Orthosis EUDAMED
- Model / Reference
- 68 EUDAMEDNC91258 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627912587 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-68-RM EUDAMED
- Direct Marketing DI
- 00768627912587 EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-FINGERS 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
Comfort Cool D-Ring Thumb/Wrist, LXL Wristv Orthosis 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-68-RM | 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 f74ac724-6d58-4f31-bdb7-33f7e2dbd7ed 61 fields · synced Jul 9, 2026