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Orthothermic CMC Restriction, MD, Right
EUDAMEDClass I (EU MDR)
Ref NC79675Model 4364Ref NC79677
Identity
- Trade Name
- Orthothermic CMC Restriction, MD, Right EUDAMEDOrthothermic CMC Restriction, MD+, Right EUDAMED
- Device Name
- OrthoThermic Thumb CMC Restriction Splint EUDAMED
- Model / Reference
- 4364 EUDAMEDNC79675 EUDAMEDNC79677 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627015387 EUDAMED00768627015400 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-4364-PK EUDAMED
- Direct Marketing DI
- 00768627015387 EUDAMED00768627015400 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, 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 (2)
- EUDAMED 43b4dfb1-bd06-404f-a382-ba79a778cafe 61 fields · synced Jul 24, 2026
- EUDAMED e57332ca-d60b-4607-9f3a-27c1fafee385 61 fields · synced May 19, 2026