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Comfort Cool Thumb Abductor Strap, SM
EUDAMEDClass I (EU MDR)
Ref NC79520Model 612
Identity
- Trade Name
- Comfort Cool Thumb Abductor Strap, SM EUDAMED
- Device Name
- Comfort Cool Thumb Abductor Strap EUDAMED
- Model / Reference
- 612 EUDAMEDNC79520 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627795203 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-612-67 EUDAMED
- Direct Marketing DI
- 00768627795203 EUDAMED
- EMDN Code
- Y060603 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 Thumb Abductor Strap, SM 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-612-67 | 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 315d1628-526d-46ae-a555-7ef3fd7b58a8 61 fields · synced Jun 17, 2026