Electric Wheelchairs
by Zhejiang Topwe Tools Manufacturing Co., Ltd EUDAMED
Active
Ref N818 (MAX CARBON 1497SE)Model W601 W602 W603 W605 W606 W607 W608 N817 N817A N817C N817M N818 N819 F1406 F1408 F1410 F1412 GT520 GT521 GT522 GT525 GT528 X501 X502 X503 X505 X506 X507 X508 X801 X802 X803 X805 X806 X807 X808 TP 817 TP 818 TP 819
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697411805WCEU01LB | Date16 Jan 2025 | 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- Withdrawn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
- wheel chair
- Model / Reference
- W601 W602 W603 W605 W606 W607 W608 N817 N817A N817C N817M N818 N819 F1406 F1408 F1410 F1412 GT520 GT521 GT522 GT525 GT528 X501 X502 X503 X505 X506 X507 X508 X801 X802 X803 X805 X806 X807 X808 TP 817 TP 818 TP 819, N818 (MAX CARBON 1497SE)
- Primary DI / UDI-DI
- 06974118050087
- Basic UDI-DI
- 697411805WCEU01LB
- EMDN Code
- Y122127 Electric wheelchairs
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000043163
- Authorised representative
- Sungo Cert GmbH DE-AR-000010869
Other devices from Zhejiang Topwe Tools Manufacturing 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