Power Assist Drive Unit
by WU’S Tech Co., Ltd. 5 variants
Ref PS-HAModel Power Assist Drive Unit
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number471987290PS3860JF 04719872909019 | Date15 Aug 2025 | StatusActive |
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- Withdrawn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 Active
Specification
- Device Name
- Power Assist Drive Unit
- Model / Reference
- Power Assist Drive Unit, PS-HA
- Primary DI / UDI-DI
- 04719872909019
- Basic UDI-DI
- 471987290PS3860JF
- Direct Marketing DI
- 04719872909019
- EMDN Code
- Y122410 Electric propulsion unit
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- TW-MF-000011590
- Authorised representative
- KOMAS Medical Technology GmbH DE-AR-000045617
Other devices from WU’S Tech 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