Electric Wheelchair
by Yongkang Hengyi Vehicle Co., Ltd 6 variants
Ref HC831NModel HS801W, HS802W, HS803W, HS804W, HS805W, HS806W, HS806AW, HS806BW, HS807W, HA808N, HA808AN, HA809N, HA810N, HA811W, HA812N, HA813N, HA814N, HA815N, HA815AN, HA816N, HA817N, HA818W, HA818AW, HA818BW, HC819N, HC820N, HC820AN, etc
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697747409EWEU01WX 06977474090384 | Date20 Jun 2024 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Electric Wheelchair
- Model / Reference
- HS801W, HS802W, HS803W, HS804W, HS805W, HS806W, HS806AW, HS806BW, HS807W, HA808N, HA808AN, HA809N, HA810N, HA811W, HA812N, HA813N, HA814N, HA815N, HA815AN, HA816N, HA817N, HA818W, HA818AW, HA818BW, HC819N, HC820N, HC820AN, etc, HC831N
- Primary DI / UDI-DI
- 06977474090384
- Basic UDI-DI
- 697747409EWEU01WX
- EMDN Code
- Y122127 Electric wheelchairs
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000042716
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Yongkang Hengyi Vehicle Co., Ltd
Properties
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