Identity
- Trade Name
- DONJOY NEXTEP WALKER EUDAMED
- Device Name
- DONJOY NEXTEP WALKER EUDAMED
- Model / Reference
- 82-114-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 01220000531697 EUDAMED
- Basic UDI-DI
- 122000053282112PB EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT 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
Category: Ankle/foot orthosis
Donjoy Nextep Walker by Span Link International Llc — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 b1f9b4c8-a692-4f2f-8208-b43001e9a15a 61 fields · synced Jul 29, 2026