← Back to catalogue
Comfort Cool Gladiator Wrist & Thumb, Large, Right
EUDAMEDClass I (EU MDR)
Ref NC86655Model 4113
Identity
- Trade Name
- Comfort Cool Gladiator Wrist & Thumb, Large, Right EUDAMED
- Device Name
- Gladiator Wrist Thumb Orthosis EUDAMED
- Model / Reference
- 4113 EUDAMEDNC86655 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627013826 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-4113-N9 EUDAMED
- Direct Marketing DI
- 00768627013826 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, 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-4113-N9 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- North Coast Medical Inc.
- EUDAMED SRN
- US-MF-000009087
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (1)
- EUDAMED 1b2c6fee-1b0b-4c1d-bfe8-cb5f7b5cd8e9 61 fields · synced Jun 18, 2026