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Rollator
EUDAMEDClass I (EU MDR)
Ref ROL08Model 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 EUDAMEDROL08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978356680273 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
Category: Walking chair, non-foldable
Rollator by Hebei Dansong 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 | 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 b000205e-d48a-4338-8238-8f1ed9d0ec62 61 fields · synced Jun 19, 2026