Electric Wheelchair
by Hebei Huaen Medical Devices Co., Ltd. EUDAMED
Active
Ref HELY-D-07-20ALModel HELY-D-01-12AQ HELY-D-01-12AL HELY-D-02-12AQ HELY-D-02-12AL HELY-D-02-20AL HELY-D-02-30AL HELY-D-02-40AL HELY-D-03-12AL-L HELY-D-03-20AL-L HELY-D-03-30AL-L HELY-D-04-12AL-L HELY-D-04-20AL-L HELY-D-04-30AL-L HELY-D-05-12AQ etc
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number698021129ELEWG9 | Date22 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- Model / Reference
- HELY-D-01-12AQ HELY-D-01-12AL HELY-D-02-12AQ HELY-D-02-12AL HELY-D-02-20AL HELY-D-02-30AL HELY-D-02-40AL HELY-D-03-12AL-L HELY-D-03-20AL-L HELY-D-03-30AL-L HELY-D-04-12AL-L HELY-D-04-20AL-L HELY-D-04-30AL-L HELY-D-05-12AQ etc, HELY-D-07-20AL
- Primary DI / UDI-DI
- 06980211290381
- Basic UDI-DI
- 698021129ELEWG9
- EMDN Code
- Y122127 Electric wheelchairs
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000056467
- Authorised representative
- HyperCert Limited B.V. NL-AR-000047746
Other devices from Hebei Huaen Medical Devices Co., Ltd.
See all devices from Hebei Huaen Medical Devices 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