Manual Wheelchair
by Hangzhou Enti Technology Co., Ltd 12 variants
Ref TLS777L-Q36 size:30Model TLS779LQ-36, TLS777LQ-36, TLS778LQ-36, TLS785LQ-36, TLS779LQF1-36, FS779LQF1-36, FS205LHQ, FS251LHPQ, FS903LAJPQF9, FS957LQ, FS950LBPQ, FS959LQ, FS955L, FS903LQ, FS908LQF19, FS908LAJPF21, FS218LQ, FS952LCQ, FS250LCPQ, FS253LACHQ, etc
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 | Number697638547MWC001UX 06976385470056 | Date15 May 2023 | 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- Withdrawn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
- TLS779LQ-36, TLS777LQ-36, TLS778LQ-36, TLS785LQ-36, TLS779LQF1-36, FS779LQF1-36, FS205LHQ, FS251LHPQ, FS903LAJPQF9, FS957LQ, FS950LBPQ, FS959LQ, FS955L, FS903LQ, FS908LQF19, FS908LAJPF21, FS218LQ, FS952LCQ, FS250LCPQ, FS253LACHQ, etc, TLS777L-Q36 size:30
- Primary DI / UDI-DI
- 06976385470056
- Basic UDI-DI
- 697638547MWC001UX
- Direct Marketing DI
- 06976385470056
- EMDN Code
- Y122103 Push wheelchairs
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000035404
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Hangzhou Enti Technology 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