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knee walker
EUDAMEDClass I (EU MDR)
Ref 8012Model 8001,8002,8003,8004,8005,8006, 8007,8008,8009,8010,8011,8012, 8013,8014,8015
Identity
- Device Name
- knee walker EUDAMED
- Model / Reference
- 8001,8002,8003,8004,8005,8006, 8007,8008,8009,8010,8011,8012, 8013,8014,8015 EUDAMED8012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974853678126 EUDAMED
- Basic UDI-DI
- 6974853678007GX 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
knee walker by Foshan Highway Medical Equipment 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 | 6974853678007GX | 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 c622228e-903d-48cf-a787-af7ccd0bd343 61 fields · synced Oct 8, 2026