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Rollator
EUDAMEDClass I (EU MDR)
Ref RF05-0011Model RF05-0001、RF05-0002、RF05-0003、RF05-0004、RF05-0005、RF05-0006、RF05-0007、RF05-0008、RF05-0009、RF05-0010、RF05-0011,etc
Identity
- Device Name
- Rollator EUDAMED
- Model / Reference
- RF05-0001、RF05-0002、RF05-0003、RF05-0004、RF05-0005、RF05-0006、RF05-0007、RF05-0008、RF05-0009、RF05-0010、RF05-0011,etc EUDAMEDRF05-0011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16975770175108 EUDAMED
- Basic UDI-DI
- 697577017RF05ROLLATOR56 EUDAMED
- EMDN Code
- Y120612 WALKING TROLLEYS 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 Foshan Rafu 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 | 697577017RF05ROLLATOR56 | Class I | Active |
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Manufacturer
- Manufacturer
- Foshan Rafu Medical Technology CO., LTD
- EUDAMED SRN
- CN-MF-000029364
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 6ce6eb6f-9ef3-4e44-bc75-5849aba1a28a 61 fields · synced Jun 19, 2026