Electrically powered wheelchairs
by AndCare(Guangdong)Intelligent Technology Co., Ltd. EUDAMED
Active
Ref AC575LEModel AC575LE,AC576LGE,AC578TE,AC579TE,AC576LE,AC908E,AC908LGCE,AC863LE,AC571E,AC572E，AC573E,AC512E,AC513LE,AC501LE,AC502E
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697832295EPW001QA | Date8 May 2026 | 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- Withdrawn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
- Electrically powered wheelchairs
- Model / Reference
- AC575LE, AC576LGE, AC578TE, AC579TE, AC576LE, AC908E, AC908LGCE, AC863LE, AC571E, AC572E，AC573E, AC512E, AC513LE, AC501LE, AC502E
- Primary DI / UDI-DI
- 06978322950010
- Basic UDI-DI
- 697832295EPW001QA
- EMDN Code
- Y122127 Electric wheelchairs
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000053011
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from AndCare(Guangdong)Intelligent 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