Elesmart
by Cnebikes Co., Ltd China EUDAMED
Ref A8Model WH12A,WH12AS,WH12B,WH12BS,WH12C,WH12CS,WH16A,WH16AS,WH16B,WH16BS,WH16C,WH16CS,WH20A,WH20AS,B1,B2,B3,B4,B5,B6,B7,B8,B9,B10,A1,A2,A3,A4,A5,A6,A7,A8,A9,A10
EMDN Y122411
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697700725EWH001GY | Date18 Dec 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- wheelchair power attachment
- Model / Reference
- WH12A, WH12AS, WH12B, WH12BS, WH12C, WH12CS, WH16A, WH16AS, WH16B, WH16BS, WH16C, WH16CS, WH20A, WH20AS, B1, B2, B3, B4, B5, B6, B7, B8, B9, B10, A1, A2, A3, A4, A5, A6, A7, A8, A9, A10
- Primary DI / UDI-DI
- 06977007250315
- Basic UDI-DI
- 697700725EWH001GY
- EMDN Code
- Y122411 Wheelchair unicycle
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000039101
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Cnebikes Co., Ltd
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED a8fee89d-123a-49fa-962d-903e28daa620