Manual Wheelchair
by Zhejiang Feilechi Medical Equipment Co., Ltd.
Ref FLCW05Model FLCW05，FLCW05-01，FLCW05-02，FLCW05-03，FLCW05-04，FLCW05-05，FLCW05-06，FLCW05-07，FLCW05-08，FLCW05-09，FLCW05-10，FLCW05-11，FLCW05-12，FLCW05-13，FLCW05-14，FLCW05-15
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 | Number697830568MW001N8 06978305681009 | Date6 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- Withdrawn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
- Manual Wheelchair
- Model / Reference
- FLCW05，FLCW05-01，FLCW05-02，FLCW05-03，FLCW05-04，FLCW05-05，FLCW05-06，FLCW05-07，FLCW05-08，FLCW05-09，FLCW05-10，FLCW05-11，FLCW05-12，FLCW05-13，FLCW05-14，FLCW05-15, FLCW05
- Primary DI / UDI-DI
- 06978305681009
- Basic UDI-DI
- 697830568MW001N8
- EMDN Code
- Y122127 Electric wheelchairs
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000048168
- Authorised representative
- Sungo Cert GmbH DE-AR-000010869
Other devices from Zhejiang Feilechi Medical Equipment Co., Ltd.
See all devices from Zhejiang Feilechi Medical Equipment 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