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Standard Walker, Black, X-Small
EUDAMEDClass I (EU MDR)
Ref 11002BLKModel Walking BraceRef 11003BLK
Identity
- Trade Name
- Standard Walker, Black, X-Small EUDAMEDStandard Walker, Black, Small EUDAMED
- Device Name
- Walker / Foot-Ankle EUDAMED
- Model / Reference
- Walking Brace EUDAMED11002BLK EUDAMED11003BLK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810047431695 EUDAMED00810047431732 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
Category: Ankle/foot orthosis
Standard Walker, Black, X-Small by Ovation Medical — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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- Rebound® Air Walker LT — Össur Iceland ehf. · Class I
- Strp Blank Insert Only, SA, A/B Size, 3in Free Mot — Becker Orthopedic Appliance Company · Class I
- STABIBOOT 3D — GROUPE SOBER SAS · Class I
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 5c432876-d9ba-4aad-8b51-502793cbb37d 61 fields · synced Jul 31, 2026
- EUDAMED f25ed7bb-ae19-4d9b-bf2b-86823d14969b 61 fields · synced May 18, 2026