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Comfort Cool CMC Abduction R, Youth/XS
EUDAMEDClass I (EU MDR)
Ref NC79493Model 599
Identity
- Trade Name
- Comfort Cool CMC Abduction R,Youth/XS EUDAMED
- Device Name
- Comfort Cool Thumb CMC Abduction Orthosis EUDAMED
- Model / Reference
- 599 EUDAMEDNC79493 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627794930 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-599-7V EUDAMED
- Direct Marketing DI
- 00768627794930 EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-FINGERS ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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 CMC Abduction R, Youth/XS 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-599-7V | 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 fa3ab3b2-178d-438f-bd03-5a3c0396c170 61 fields · synced Jun 19, 2026