eFOLDi Powerchair
Ref HBLD3-D
Withdrawn
CE MDR, withdrawn
Ended
Withdrawn
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5065002287SUN00717B 05065002287021 | Date4 Jul 2022 | StatusWithdrawn |
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- Withdrawn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European Union — CE/MDR Withdrawn
Specification
- Model / Reference
- HBLD3-D
- Primary DI / UDI-DI
- 05065002287021
- Basic UDI-DI
- 5065002287SUN00717B
- Direct Marketing DI
- 05065002287021
- EMDN Code
- Y122127 Electric wheelchairs
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- GB-MF-000025555
- Authorised representative
- MedPath GmbH DE-AR-000000087
Other devices from SunTech UK 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