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rollator
EUDAMEDClass I (EU MDR)
Ref UR435Model UR435, UR435A, UR436A, UR487, UW661S, UR432A, UW662, UR483A, UR420A, UR413A, UR408B, UR409S, UR410S, UR418S, UR411A, UR422S, UR301A, UR388A, UR387S, UR389A, UR433A
Identity
- Device Name
- rollator EUDAMED
- Model / Reference
- UR435, UR435A, UR436A, UR487, UW661S, UR432A, UW662, UR483A, UR420A, UR413A, UR408B, UR409S, UR410S, UR418S, UR411A, UR422S, UR301A, UR388A, UR387S, UR389A, UR433A EUDAMEDUR435 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975821401784 EUDAMED
- Basic UDI-DI
- 697582140REU01MZ EUDAMED
- EMDN Code
- Y120612 WALKING TROLLEYS 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
rollator by Jiangyin Unixcare Medical Devices 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 | 697582140REU01MZ | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangyin Unixcare Medical Devices Co., Ltd
- EUDAMED SRN
- CN-MF-000041210
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED f75d67f8-0f0a-4427-abd0-74ab7f8a09a2 61 fields · synced Jul 10, 2026