← Back to catalogue
Comfort Cool Thumb CMC Restriction Splint, RS+
EUDAMEDClass I (EU MDR)
Ref NC79557Model 77Ref NC79563
Identity
- Trade Name
- Comfort Cool Thumb CMC Restriction Splint, RS+ EUDAMEDComfort Cool Thumb CMC Restriction Splint, RS EUDAMED
- Device Name
- Comfort Cool Thumb CMC Restriction Splint EUDAMED
- Model / Reference
- 77 EUDAMEDNC79557 EUDAMEDNC79563 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627795579 EUDAMED00768627795630 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-77-RP EUDAMED
- Direct Marketing DI
- 00768627795579 EUDAMED00768627795630 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, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- North Coast Medical Inc.
- EUDAMED SRN
- US-MF-000009087
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (2)
- EUDAMED e2b5073d-4cbc-4adb-b2bf-12acdc0767b0 61 fields · synced Jul 29, 2026
- EUDAMED a4ca54c7-f457-4570-817b-bc57eac465b8 61 fields · synced May 19, 2026