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Short Pneumatic Walker, Blue, X-Small
EUDAMEDClass I (EU MDR)
Ref 10102BLUModel Walking BraceRef 10103BLU
Identity
- Trade Name
- Short Pneumatic Walker, Blue, X-Small EUDAMEDShort Pneumatic Walker, Blue, Small EUDAMED
- Device Name
- Walker / Foot-Ankle EUDAMED
- Model / Reference
- Walking Brace EUDAMED10102BLU EUDAMED10103BLU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810047431503 EUDAMED00810047431541 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
Short Pneumatic Walker, Blue, X-Small by Ovation Medical — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
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 723c07b7-d48f-4a3f-864a-d1bb2f222ae5 61 fields · synced Jul 15, 2026
- EUDAMED 7c79be59-ccad-4967-ab7f-ff24ee662bd4 61 fields · synced May 18, 2026