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Comfort Cool Thumb CMC Restriction Splint, R, XX-Smal
EUDAMEDClass I (EU MDR)
Ref NC79547Model 77
Identity
- Trade Name
- Comfort Cool Thumb CMC Restriction Splint, R, XX-Smal EUDAMED
- Device Name
- Comfort Cool Thumb CMC Restriction Splint EUDAMED
- Model / Reference
- 77 EUDAMEDNC79547 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627795470 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-77-RP EUDAMED
- Direct Marketing DI
- 00768627795470 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, R, XX-Smal 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 (1)
- EUDAMED 0283df69-eb31-48cf-84ad-d896eaf81095 61 fields · synced Jun 17, 2026