Identity
- Trade Name
- Smartwalker kurz small EUDAMED
- Device Name
- Smartwalker EUDAMED
- Model / Reference
- 103609304 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251746611388 EUDAMED
- Basic UDI-DI
- 42517466018NE EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Smartwalker kurz small by Achim Ruthner GmbH — 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 | 42517466018NE | Class I | Active |
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Manufacturer
- Manufacturer
- Achim Ruthner GmbH
- EUDAMED SRN
- DE-MF-000016101
Sources (1)
- EUDAMED 83bcd989-0d23-4d44-8536-80d997cfd4fd 61 fields · synced Jun 18, 2026