Manual Wheelchair
by Hebei Huaen Medical Devices Co., Ltd. EUDAMED
Active
Ref HELY-S-07Model HELY-S-01 HELY-S-02 HELY-S-03 HELY-S-04 HELY-S-05 HELY-S-06 HELY-S-07 HELY-S-08 HELY-S-09 HELY-S-10 HELY-S-11 HELY-S-12
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number698021129MANWH5 | 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- Withdrawn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-S-01 HELY-S-02 HELY-S-03 HELY-S-04 HELY-S-05 HELY-S-06 HELY-S-07 HELY-S-08 HELY-S-09 HELY-S-10 HELY-S-11 HELY-S-12, HELY-S-07
- Primary DI / UDI-DI
- 06980211290077
- Basic UDI-DI
- 698021129MANWH5
- EMDN Code
- Y122109 Front self-propelled 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