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Rollator
EUDAMEDClass I (EU MDR)
Ref FHTS25Model 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 EUDAMEDFHTS25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974827540824 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
Rollator by Tousda medical technology 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 | 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 9cdc4d7c-0473-49de-8a73-25ae026a3fba 61 fields · synced Jun 19, 2026