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Standard Pneumatic Walker, Red, X-Small
EUDAMEDClass I (EU MDR)
Ref 10002REDModel Walking BraceRef 10003RED
Identity
- Trade Name
- Standard Pneumatic Walker, Red, X-Small EUDAMEDStandard Pneumatic Walker, Red, Small EUDAMED
- Device Name
- Walker / Foot-Ankle EUDAMED
- Model / Reference
- Walking Brace EUDAMED10002RED EUDAMED10003RED EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810047431329 EUDAMED00810047431367 EUDAMED
- Basic UDI-DI
- 081004743AZP 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
Standard Pneumatic Walker, Red, X-Small by Ovation Medical — 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 | 081004743AZP | Class I | Active |
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Manufacturer
- Manufacturer
- Ovation Medical
- EUDAMED SRN
- US-MF-000051616
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED f166d714-105f-42b7-9b5c-0df1fba22ca0 61 fields · synced Jul 23, 2026
- EUDAMED ba94523a-4028-4663-82b5-0794058a15e7 61 fields · synced May 17, 2026