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OrthoThermic Thumb CMC Restriction, LG+, Right
EUDAMEDClass I (EU MDR)
Ref NC79681Model 4364
Identity
- Trade Name
- OrthoThermic Thumb CMC Restriction, LG+, Right EUDAMED
- Device Name
- OrthoThermic Thumb CMC Restriction Splint EUDAMED
- Model / Reference
- 4364 EUDAMEDNC79681 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627015448 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-4364-PK EUDAMED
- Direct Marketing DI
- 00768627015448 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
OrthoThermic Thumb CMC Restriction, LG+, Right 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-4364-PK | 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 566c6121-2860-42ae-8a35-877f8f73e6fd 61 fields · synced Jun 18, 2026