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Comfort Cool Gladiator Wrist & Thumb, XX-Large, Left
EUDAMEDClass I (EU MDR)
Ref NC86658Model 4113
Identity
- Trade Name
- Comfort Cool Gladiator Wrist & Thumb, XX-Large, Left EUDAMED
- Device Name
- Gladiator Wrist Thumb Orthosis EUDAMED
- Model / Reference
- 4113 EUDAMEDNC86658 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627014779 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-4113-N9 EUDAMED
- Direct Marketing DI
- 00768627014779 EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-FINGERS 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 & Thumb, XX-Large, Left 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-4113-N9 | 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 04efd979-5cb6-4028-b261-647936edf588 61 fields · synced Jun 19, 2026