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Rollator
EUDAMEDClass I (EU MDR)
Ref ROL10Model RO01,RO02,RO03,RO04,RO05,RO06,RO07,RO08,RO09,RO10,ROL01,ROL02,ROL03,ROL04,ROL05,ROL06,ROL07,ROL08,ROL09,ROL10
Identity
- Device Name
- ROLLATOR EUDAMED
- Model / Reference
- RO01,RO02,RO03,RO04,RO05,RO06,RO07,RO08,RO09,RO10,ROL01,ROL02,ROL03,ROL04,ROL05,ROL06,ROL07,ROL08,ROL09,ROL10 EUDAMEDROL10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978356680297 EUDAMED
- Basic UDI-DI
- 697835668ROLLATOR4Y EUDAMED
- EMDN Code
- Y120606 WHEELED WALKER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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 Hebei Dansong 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 | 697835668ROLLATOR4Y | Class I | Active |
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Manufacturer
- Manufacturer
- Hebei Dansong Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000047302
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 524c4640-3fbd-4f8b-9440-91c5c63044a6 61 fields · synced Jun 11, 2026