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Norco Ortho Foam PIP Extension Orthotic, Medium
EUDAMEDClass I (EU MDR)
Ref NC85501-3Model 3284
Identity
- Trade Name
- Norco Ortho Foam PIP Extension Orthotic, Medium EUDAMED
- Device Name
- Ortho Foam PIP Extension Orthotic EUDAMED
- Model / Reference
- 3284 EUDAMEDNC85501-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627001847 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-3284-PB EUDAMED
- Direct Marketing DI
- 00768627001847 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, Medium 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 6d2103be-3331-4843-bef0-c851a434e3e2 61 fields · synced Jul 29, 2026