Electric Wheelchair
by Changzhou Airwheel Technology Co., Ltd. EUDAMED
Active
Ref H3SModel H3/H3S/H3P/H3T/H3TS/H3TS+/H3PC/H3PS/H3P10
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69256112EW001H6 | Date19 May 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Electric Wheelchair
- Model / Reference
- H3/H3S/H3P/H3T/H3TS/H3TS+/H3PC/H3PS/H3P10, H3S
- Primary DI / UDI-DI
- 06925611200011
- Basic UDI-DI
- 69256112EW001H6
- EMDN Code
- Y122127 Electric wheelchairs
- Device Class
- Class I
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CN-MF-000047837
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Changzhou Airwheel Technology 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