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Comfort Cool Pronation Supination Splints R Med
EUDAMEDClass I (EU MDR)
Ref NC34805Model 653
Identity
- Trade Name
- Comfort Cool Pronation Supination Splints R Med EUDAMED
- Device Name
- Comfort Cool Pronation-Supination Splints EUDAMED
- Model / Reference
- 653 EUDAMEDNC34805 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627348058 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-653-6W EUDAMED
- Direct Marketing DI
- 00768627348058 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 Med is a medical device designed to provide support and stability for individuals with pronated or supinated foot deformities. It is used to prevent complications such as foot ulcers, hammertoes, and toe deformities.
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 6abba3e2-9857-492d-90bd-d82c1c09e376 61 fields · synced Jul 28, 2026