Identity
- Trade Name
- DONJOY NEXTEP WALKER EUDAMED
- Device Name
- DONJOY NEXTEP WALKER EUDAMED
- Model / Reference
- 82-112-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 01220000531666 EUDAMED
- Basic UDI-DI
- 122000053282112PB EUDAMED
- EMDN Code
- Y060606 HAND ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Donjoy Nextep Walker by Span Link International Llc — 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 | 122000053282112PB | Class I | Active |
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Manufacturer
- Manufacturer
- Span Link International, LLC
- EUDAMED SRN
- US-MF-000012261
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 3027faec-9939-485a-992d-a363d5c345b7 61 fields · synced Jul 10, 2026