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Rollator
EUDAMEDClass I (EU MDR)
Ref RE462Model RE401LH, RE401LH-1, RE402LH, RE403L, RE404H-1, RE405, RE406H, RE406L-1, RE406L-2, RE407H, RE408LH, RE409LH, RE410LH, RE411LH, RE412LH,etc.
Identity
- Device Name
- ROLLATOR EUDAMED
- Model / Reference
- RE401LH, RE401LH-1, RE402LH, RE403L, RE404H-1, RE405, RE406H, RE406L-1, RE406L-2, RE407H, RE408LH, RE409LH, RE410LH, RE411LH, RE412LH,etc. EUDAMEDRE462 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976791162729 EUDAMED
- Basic UDI-DI
- 697679116ROLLATORZ5 EUDAMED
- EMDN Code
- Y120606 WHEELED WALKER 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
Category: Walking chair, non-foldable
Rollator by Foshan Yufukang Import And Export Trading Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Walking chair, non-foldable.
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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 | 697679116ROLLATORZ5 | Class I | Active |
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Manufacturer
- Manufacturer
- Foshan Yufukang Import And Export Trading Ltd
- EUDAMED SRN
- CN-MF-000037839
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED e17f36a3-2c43-49c8-b2ba-a6de8f86a5fa 61 fields · synced Jun 20, 2026