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Rollator
EUDAMEDClass I (EU MDR)
Ref RO 02Model FHT9146L、FHT9145L 、FHT9144L、FHT9143、FHT9142、RO 02、FHT9144（3）L、FHTS01L、FHTS02L、FHTS03L、FHTS04L、FHTS05L、FHTS06L、FHTS10、FHTS20、FHTS21、FHTS22、FHTS23、etc
Identity
- Device Name
- ROLLATOR EUDAMED
- Model / Reference
- FHT9146L、FHT9145L 、FHT9144L、FHT9143、FHT9142、RO 02、FHT9144（3）L、FHTS01L、FHTS02L、FHTS03L、FHTS04L、FHTS05L、FHTS06L、FHTS10、FHTS20、FHTS21、FHTS22、FHTS23、etc EUDAMEDRO 02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974827540688 EUDAMED
- Basic UDI-DI
- 697482754ROLLATORXM EUDAMED
- EMDN Code
- Y120606 WHEELED WALKER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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 Tousda medical technology co.，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 | 697482754ROLLATORXM | Class I | Active |
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Manufacturer
- Manufacturer
- Tousda medical technology co.，Ltd.
- EUDAMED SRN
- CN-MF-000013156
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 59c975df-f483-4277-bf6c-639fc2c2e742 61 fields · synced Jun 19, 2026