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rollator
EUDAMEDClass I (EU MDR)
Ref HW-6012AModel 6008F,HW-6001,HW-6001A,HW-6001B,HW-6001C,HW-6001D,HW-6001E,HW-6001F,HW-6001G;HW-6002,HW-6002A,HW-6002B,HW-6002C,HW-6002D,HW-6002E,HW-6002F,HW-6002G;HW-6003,HW-6003A,HW-6003B,HW-6003C,HW-6003D,HW-6003E,HW-6003F,HW-6003G, etc
Identity
- Device Name
- rollator EUDAMED
- Model / Reference
- 6008F,HW-6001,HW-6001A,HW-6001B,HW-6001C,HW-6001D,HW-6001E,HW-6001F,HW-6001G;HW-6002,HW-6002A,HW-6002B,HW-6002C,HW-6002D,HW-6002E,HW-6002F,HW-6002G;HW-6003,HW-6003A,HW-6003B,HW-6003C,HW-6003D,HW-6003E,HW-6003F,HW-6003G, etc EUDAMEDHW-6012A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974853674920 EUDAMED
- Basic UDI-DI
- 6974853676001G5 EUDAMED
- EMDN Code
- Y120612 WALKING TROLLEYS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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 Highway Medical Equipment Co. Ltd — Class I — CE/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 | 6974853676001G5 | Class I | Active |
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Manufacturer
- Manufacturer
- Foshan Highway Medical Equipment Co. Ltd
- EUDAMED SRN
- CN-MF-000003238
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 16d6333f-9af1-4c34-b100-905979ea3409 61 fields · synced Oct 7, 2026