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Gladiator Wrist Orthosis, Short SM Right
EUDAMEDClass I (EU MDR)
Ref NC86641Model 4407
Identity
- Trade Name
- Gladiator Wrist Orthosis, Short SM Right EUDAMED
- Device Name
- Gladiator Short Wrist Orthosis EUDAMED
- Model / Reference
- 4407 EUDAMEDNC86641 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627015578 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-4407-P5 EUDAMED
- Direct Marketing DI
- 00768627015578 EUDAMED
- EMDN Code
- Y060612 WRIST-HAND ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
Gladiator Wrist Orthosis, Short SM 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-4407-P5 | 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 44ae3e01-37b1-4926-adea-acd96bb703d6 61 fields · synced Jun 18, 2026