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Comfort Cool Pronation Supination R Pedi
EUDAMEDClass I (EU MDR)
Ref NC34801Model 3225
Identity
- Trade Name
- Comfort Cool Pronation Supination R Pedi EUDAMED
- Device Name
- Pediatric Comfort Cool Pronation-Supination Splints EUDAMED
- Model / Reference
- 3225 EUDAMEDNC34801 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627008426 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-3225-NG EUDAMED
- Direct Marketing DI
- 00768627008426 EUDAMED
- EMDN Code
- Y060612 WRIST-HAND ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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 R Pedi 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-3225-NG | 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 bb4910bb-a8d3-4fc0-8d6c-3880af39e2d9 61 fields · synced Jun 18, 2026