electric wheelchair
by Guanchi Technology (Hebei) Co., Ltd. 50 variants
Ref GCDW-6008Model GCDW-6000....GCDW-6099 GCDW-6100....GCDW-6199 GCDW-6200...GCDW-6299 GCDW-6300....GCDW-6399 GCDW-6400....GCDW-6499 GCDW-6600....GCDW-6699 GCDW-6800....GCDW-6899
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 | Number697781226GCDW001RX 06977812260080 | Date11 Sep 2024 | 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- Withdrawn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
- electric wheelchair
- Model / Reference
- GCDW-6000....GCDW-6099 GCDW-6100....GCDW-6199 GCDW-6200...GCDW-6299 GCDW-6300....GCDW-6399 GCDW-6400....GCDW-6499 GCDW-6600....GCDW-6699 GCDW-6800....GCDW-6899, GCDW-6008
- Primary DI / UDI-DI
- 06977812260080
- Basic UDI-DI
- 697781226GCDW001RX
- EMDN Code
- Y122127 Electric wheelchairs
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000044147
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Guanchi Technology (Hebei) 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