← Back to catalogue
Orthothermic CMC Restriction, MD+, Left
EUDAMEDClass I (EU MDR)
Ref NC79676Model 4364
Identity
- Trade Name
- Orthothermic CMC Restriction, MD+, Left EUDAMED
- Device Name
- OrthoThermic Thumb CMC Restriction Splint EUDAMED
- Model / Reference
- 4364 EUDAMEDNC79676 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627015394 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-4364-PK EUDAMED
- Direct Marketing DI
- 00768627015394 EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-FINGERS ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 CMC Restriction, MD+, Left 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 |
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 (1)
- EUDAMED e74ff6cf-b9be-410a-b3e3-c984f7bf4005 61 fields · synced Jul 18, 2026