Manual wheelchair
by guangdong qikang medical technology co., ltd
Ref MW001Model QK203 Series、QK204 Series、QK207 Series、QK208 Series、QK209 Series、QK210 Series、QK211 Series、QK212 Series、QK218 Series、QK250 Series、QK251 Series、QK253 Series、QK258 Series、QK606 Series、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 | Number697270968MW001NE 06972709680019 | Date2 Jun 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- Withdrawn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
- QK203 Series、QK204 Series、QK207 Series、QK208 Series、QK209 Series、QK210 Series、QK211 Series、QK212 Series、QK218 Series、QK250 Series、QK251 Series、QK253 Series、QK258 Series、QK606 Series、etc, MW001
- Primary DI / UDI-DI
- 06972709680019
- Basic UDI-DI
- 697270968MW001NE
- Direct Marketing DI
- 06972709680019
- EMDN Code
- Y122103 Push wheelchairs
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000035093
- Authorised representative
- Sungo Cert GmbH DE-AR-000010869
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