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Comfort Cool Gladiator Wrist Orthosis, Large, Right
EUDAMEDClass I (EU MDR)
Ref NC86665Model 3881
Identity
- Trade Name
- Comfort Cool Gladiator Wrist Orthosis, Large, Right EUDAMED
- Device Name
- Gladiator Wrist Orthosis EUDAMED
- Model / Reference
- 3881 EUDAMEDNC86665 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627013925 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-3881-QC EUDAMED
- Direct Marketing DI
- 00768627013925 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 Gladiator Wrist Orthosis, Large, Right 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-3881-QC | 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 e2eff945-9a30-4113-97a4-f2e0afbe3b28 61 fields · synced Jul 17, 2026