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Comfort Cool Thumb CMC Restriction Splint, Bg, RS+
EUDAMEDClass I (EU MDR)
Ref NC79583Model 77Ref NC79581
Identity
- Trade Name
- Comfort Cool Thumb CMC Restriction Splint, Bg, RS+ EUDAMEDComfort Cool Thumb CMC Restriction Splint, Bg, RS EUDAMED
- Device Name
- Comfort Cool Thumb CMC Restriction Splint EUDAMED
- Model / Reference
- 77 EUDAMEDNC79583 EUDAMEDNC79581 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627795838 EUDAMED00768627795814 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-77-RP EUDAMED
- Direct Marketing DI
- 00768627795838 EUDAMED00768627795814 EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-FINGERS ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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 Restriction Splint, Bg, RS+ 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-77-RP | 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 9d57c5c2-408f-468c-bbd8-b571a8d69ef0 61 fields · synced Jul 17, 2026
- EUDAMED 3544a0d6-f872-42ad-b95f-ded3f8a2907e 61 fields · synced May 18, 2026