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Wheelchair
EUDAMEDClass I (EU MDR)
Ref SKW8070Model SKW8001、SKW8001-12、SKW8002、SKW8002A、SKW8002B、SKW8002C、SKW8002D、SKW8003、SKW8004、SKW8005、SKW8006、SKW8008、SKW8009、SKW8010、SKW8012、SKW8020、etc
Identity
- Device Name
- Wheelchair EUDAMED
- Model / Reference
- SKW8001、SKW8001-12、SKW8002、SKW8002A、SKW8002B、SKW8002C、SKW8002D、SKW8003、SKW8004、SKW8005、SKW8006、SKW8008、SKW8009、SKW8010、SKW8012、SKW8020、etc EUDAMEDSKW8070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979436860653 EUDAMED
- Basic UDI-DI
- 697943686WheelchairX8 EUDAMED
- EMDN Code
- Y122103 PUSH WHEELCHAIRS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Wheelchair by Danyang Sunco Machinery 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 | 697943686WheelchairX8 | Class I | Active |
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Manufacturer
- Manufacturer
- Danyang Sunco Machinery Co.ltd
- EUDAMED SRN
- CN-MF-000051111
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 09f0e124-f5e8-405d-9de2-04a471473e95 61 fields · synced Jun 8, 2026