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Norco Ortho Foam PIP Extension Orthotic, Large
EUDAMEDClass I (EU MDR)
Ref NC85501-4Model 3284
Identity
- Trade Name
- Norco Ortho Foam PIP Extension Orthotic, Large EUDAMED
- Device Name
- Ortho Foam PIP Extension Orthotic EUDAMED
- Model / Reference
- 3284 EUDAMEDNC85501-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627001854 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-3284-PB EUDAMED
- Direct Marketing DI
- 00768627001854 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
Norco Ortho Foam PIP Extension Orthotic, Large 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-3284-PB | 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 9654189f-97c0-46e7-9560-182f75cb93a5 61 fields · synced Jun 20, 2026