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Rollator
EUDAMEDClass I (EU MDR)
Ref FHTS01LModel FHT9146L、FHT9145L 、FHT9144L、FHT9143、FHT9142、RO 02、FHT9144(3)L、FHTS01L、FHTS02L、FHTS03L、FHTS04L、FHTS05L、FHTS06L、FHTS10、FHTS20、FHTS21、FHTS22、FHTS23、etcRef FHT9144LRef FHTS03LRef FHTS21Ref FHTS02LRef FHTS27Ref FHTS04LRef FHT9143Ref FHT9144(3)LRef FHTS06LRef FHTS33Ref FHTS10Ref FHTS20Ref FHTS45Ref FHTS34Ref FHT9145L Ref FHTS35Ref FHTS28Ref FHTS22
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 EUDAMEDFHTS01L EUDAMEDFHT9144L EUDAMEDFHTS03L EUDAMEDFHTS21 EUDAMEDFHTS02L EUDAMEDFHTS27 EUDAMEDFHTS04L EUDAMEDFHT9143 EUDAMEDFHT9144(3)L EUDAMEDFHTS06L EUDAMEDFHTS33 EUDAMEDFHTS10 EUDAMEDFHTS20 EUDAMEDFHTS45 EUDAMEDFHTS34 EUDAMEDFHT9145L EUDAMEDFHTS35 EUDAMEDFHTS28 EUDAMEDFHTS22 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974827540701 EUDAMED06974827540657 EUDAMED06974827540725 EUDAMED06974827540787 EUDAMED06974827540718 EUDAMED06974827540848 EUDAMED06974827540732 EUDAMED06974827540664 EUDAMED06974827540695 EUDAMED06974827540756 EUDAMED06974827540909 EUDAMED06974827540763 EUDAMED06974827540770 EUDAMED06974827540992 EUDAMED06974827540916 EUDAMED06974827540640 EUDAMED06974827540923 EUDAMED06974827540855 EUDAMED06974827540794 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 (19)
- EUDAMED e9fd1025-e4e4-4beb-9cd8-19669efa23d6 61 fields · synced Sep 18, 2026
- EUDAMED 9aa63e26-d8cd-48c2-bfa8-cf7ef7e95e32 61 fields · synced May 16, 2026
- EUDAMED 6f7defad-3059-4b86-a893-ac7dbe67f545 61 fields · synced May 17, 2026
- EUDAMED 0958a2c0-8681-48be-ade5-27c0f80adca9 61 fields · synced May 17, 2026
- EUDAMED 9f9aa3b9-aa1c-4d8d-881c-f59add20280d 61 fields · synced May 17, 2026
- EUDAMED 63ea8c04-1946-4479-b7cb-3b7c83b9e627 61 fields · synced May 17, 2026
- EUDAMED 59a3cbb9-2928-41f4-8aa7-80587996e4f1 61 fields · synced May 17, 2026
- EUDAMED 3aa99c6e-e16c-4002-a57c-72c8d3333529 61 fields · synced May 17, 2026
- EUDAMED 6f8cbf00-e15c-4010-bf4a-2cd9d4773054 61 fields · synced May 17, 2026
- EUDAMED b3117ed8-2c63-4664-aeb0-1a4818c6da37 61 fields · synced May 17, 2026
- EUDAMED 7a282030-61ab-41e3-aa6b-71ee1370cb32 61 fields · synced May 18, 2026
- EUDAMED 30a609dd-d9e6-4788-9308-1a03e07a8e1f 61 fields · synced May 18, 2026
- EUDAMED 1e4b979b-fe14-40de-beb4-036d38e7fa31 61 fields · synced May 18, 2026
- EUDAMED 300d8933-5119-457e-80c8-b92a11b93a74 61 fields · synced May 18, 2026
- EUDAMED 4253887e-268b-4ebc-90da-e4d24347f8d6 61 fields · synced May 19, 2026
- EUDAMED ed125e32-3372-49e0-b2e0-da66cb65b1d3 61 fields · synced May 19, 2026
- EUDAMED 7f237835-1e53-4b34-814f-78a17c410dd8 61 fields · synced May 19, 2026
- EUDAMED 2669f9a2-3d4b-482a-8bda-a03d4328dd0a 61 fields · synced May 19, 2026
- EUDAMED 14c1cefa-3890-490d-92f2-03c8c301e66f 61 fields · synced May 19, 2026