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Walker Brace
EUDAMEDClass I (EU MDR)
Ref WB002Model WB001,WB002,WB003,WB004,WB005,WB006,WB007,WB008,WB009,WB010,WB012,WB013,WB102,WB103,WB104,WB202
Identity
- Device Name
- Walker Brace EUDAMED
- Model / Reference
- WB001,WB002,WB003,WB004,WB005,WB006,WB007,WB008,WB009,WB010,WB012,WB013,WB102,WB103,WB104,WB202 EUDAMEDWB002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976200100458 EUDAMED
- Basic UDI-DI
- 697620010WB0019C EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Walker Brace by Xiamen Ortocare Sports Health Co., Ltd. — 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 | 697620010WB0019C | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Ortocare Sports Health Co., Ltd.
- EUDAMED SRN
- CN-MF-000034229
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 46b981c3-2998-4fe0-9e7b-3d4f9d09e2e4 61 fields · synced Oct 7, 2026