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Comfort Cool Thumb CMC Abduction Orthosis, L LG
EUDAMEDClass I (EU MDR)
Ref NC79498Model 599Ref NC79498-P
Identity
- Trade Name
- Comfort Cool Thumb CMC Abduction Orthosis, L LG EUDAMEDComfort Cool Thumb CMC Abduction Orthosis, L LG+ EUDAMED
- Device Name
- Comfort Cool Thumb CMC Abduction Orthosis EUDAMED
- Model / Reference
- 599 EUDAMEDNC79498 EUDAMEDNC79498-P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627794985 EUDAMED00768627000550 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-599-7V EUDAMED
- Direct Marketing DI
- 00768627794985 EUDAMED00768627000550 EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-FINGERS ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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 Thumb CMC Abduction Orthosis, L LG 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 (2)
- EUDAMED d5b2856c-c409-4e17-a9da-8f6c5a3c10b4 61 fields · synced Jul 28, 2026
- EUDAMED 4f4b476c-c5b8-463d-a124-5fe6cf826c96 61 fields · synced May 19, 2026