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Comfort Cool Firm D-Ring Thumb/Wrist Orthosis, RM
EUDAMEDClass I (EU MDR)
Ref NC52995Model 4500
Identity
- Trade Name
- Comfort Cool Firm D-Ring Thumb/Wrist Orthosis, RM EUDAMED
- Device Name
- Comfort Cool Firm D-Ring Wrist/Thumb Orthosis EUDAMED
- Model / Reference
- 4500 EUDAMEDNC52995 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627529952 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-4500-NP EUDAMED
- Direct Marketing DI
- 00768627529952 EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-FINGERS ORTHOSES EUDAMED
Classification
- Device Class
- Class I 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 Firm D-Ring Thumb/Wrist Orthosis, RM 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-4500-NP | 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 1c8dd08d-0c48-4d19-99c5-31110d8f04ab 61 fields · synced Jul 12, 2026