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BraceID-ROM Walker - STD Liner- Medium (39-43)
EUDAMEDClass I (EU MDR)
Ref 12-0003-MModel 11-0003-JA
by Orthobroker
Identity
- Trade Name
- BraceID-ROM Walker - STD Liner- Medium (39-43) EUDAMED
- Device Name
- Ankle Stirrup-Junior Air EUDAMED
- Model / Reference
- 11-0003-JA EUDAMED12-0003-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404020401246 EUDAMED
- Basic UDI-DI
- 5404020402anklefootAV EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
BraceID-ROM Walker - STD Liner- Medium (39-43) by Orthobroker — 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 | 5404020402anklefootAV | Class I | Active |
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Manufacturer
- Manufacturer
- Orthobroker
- EUDAMED SRN
- BE-MF-000000331
Sources (1)
- EUDAMED 12b9f3de-3505-43fc-99fe-b236485c933e 61 fields · synced Jun 18, 2026