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Norco Ortho-Foam Terminal PIP Extension Orthotic, Sm.
EUDAMEDClass I (EU MDR)
Ref NC85507-2Model 3286
Identity
- Trade Name
- Norco Ortho-Foam Terminal PIP Extension Orthotic, Sm. EUDAMED
- Device Name
- Ortho Foam Terminal PIP Extension Orthotic EUDAMED
- Model / Reference
- 3286 EUDAMEDNC85507-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627001939 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-3286-PH EUDAMED
- Direct Marketing DI
- 00768627001939 EUDAMED
- EMDN Code
- Y060612 WRIST-HAND ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
Norco Ortho-Foam Terminal PIP Extension Orthotic, Sm. 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-3286-PH | 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 650dae76-283a-41f3-b11b-9df118bbe5a8 61 fields · synced Jul 30, 2026