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Rollator
EUDAMEDClass I (EU MDR)
Ref RO01Model RO01,RO02,RO03,RO04,RO05,RO06,RO07,RO08,RO09,RO10,ROL01,ROL02,ROL03,ROL04,ROL05,ROL06,ROL07,ROL08,ROL09,ROL10 Ref ROL01Ref RO05Ref RO10Ref ROL05Ref ROL02Ref ROL06Ref RO09Ref RO08
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 EUDAMEDRO01 EUDAMEDROL01 EUDAMEDRO05 EUDAMEDRO10 EUDAMEDROL05 EUDAMEDROL02 EUDAMEDROL06 EUDAMEDRO09 EUDAMEDRO08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978356680105 EUDAMED06978356680204 EUDAMED06978356680143 EUDAMED06978356680198 EUDAMED06978356680242 EUDAMED06978356680211 EUDAMED06978356680259 EUDAMED06978356680181 EUDAMED06978356680174 EUDAMED
- Basic UDI-DI
- 697835668ROLLATOR4Y EUDAMED
- EMDN Code
- Y120606 WHEELED WALKER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMEDItaly 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
Similar devices
Also classified as Walking chair, non-foldable.
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- Rollator — Caremaster Technology (HK) Group Co., Ltd · Class I
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 (9)
- EUDAMED e2fa85b9-0dc7-4d1a-9723-166786454f40 61 fields · synced Jul 28, 2026
- EUDAMED 4b5e3085-ccfb-48db-a385-fc7a9fc3fbef 61 fields · synced Jun 18, 2026
- EUDAMED afc029b6-0e29-4612-9fc3-94ef181df765 61 fields · synced Jul 11, 2026
- EUDAMED f8aae3d3-2808-4b0f-84b3-053bc0341d74 61 fields · synced Jul 11, 2026
- EUDAMED 3df719aa-0aae-4a55-8b96-e83c864285db 61 fields · synced Jul 17, 2026
- EUDAMED 59bbd39b-0a0f-4d35-af42-6293ce7bf3f8 61 fields · synced Jul 20, 2026
- EUDAMED 11658945-dcc3-4a41-b6c2-78e581a9e4ea 61 fields · synced Jul 23, 2026
- EUDAMED 186503bd-b5b4-4fa8-8147-d3090272fb28 61 fields · synced Jul 25, 2026
- EUDAMED 5e14c471-8108-4665-8f8d-8aac7d5bfeaa 61 fields · synced Jul 28, 2026