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Standard Pneumatic Walker, Blue, Large
EUDAMEDClass I (EU MDR)
Ref 10007BLUModel Walking Brace
Identity
- Trade Name
- Standard Pneumatic Walker, Blue, Large EUDAMED
- Device Name
- Walker / Foot-Ankle EUDAMED
- Model / Reference
- Walking Brace EUDAMED10007BLU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810047431428 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, Blue, Large 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 (1)
- EUDAMED 151ff1ea-65ab-4b09-a5ee-9f2f75a696fc 61 fields · synced Jul 13, 2026