Manual wheelchair
by Anhui Gmed Technology Co., Ltd. 287 variants
Ref FH01BModel GM001、GM002、GM003、GM003、GM004、GM005、GM006、GM007、GM008、GM009、GM010、GM011、GM012、GM013、GM014、GM015、GM016、GM017、GM018、GM019、GM020、GM021、GM022、GM023、GM024、GM025、GM026、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 | Number697780814wheelchair002U3 06977808143816 | 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- Withdrawn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
- Manual wheelchair
- Model / Reference
- GM001、GM002、GM003、GM003、GM004、GM005、GM006、GM007、GM008、GM009、GM010、GM011、GM012、GM013、GM014、GM015、GM016、GM017、GM018、GM019、GM020、GM021、GM022、GM023、GM024、GM025、GM026、etc, FH01B
- Primary DI / UDI-DI
- 06977808143816
- Basic UDI-DI
- 697780814wheelchair002U3
- EMDN Code
- Y122103 Push wheelchairs
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000044045
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Anhui Gmed 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