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Comfort Cool Pronation-Supination Splints R Sm
EUDAMEDClass I (EU MDR)
Ref NC34803Model 653
Identity
- Trade Name
- Comfort Cool Pronation-Supination Splints R Sm EUDAMED
- Device Name
- Comfort Cool Pronation-Supination Splints EUDAMED
- Model / Reference
- 653 EUDAMEDNC34803 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627348034 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-653-6W EUDAMED
- Direct Marketing DI
- 00768627348034 EUDAMED
- EMDN Code
- Y060612 WRIST-HAND ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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 Pronation-Supination Splints R 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-653-6W | 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 7584be1f-029b-43a9-a180-f8ae5eda8bec 61 fields · synced Jul 10, 2026