Guanqi
by Hustings Shuntai Kangyuan Medical Equipment Co., Ltd.
Ref A01-I, STKY-DC01Model A01-I, A01-II, A01-III, A01-IV, A02-I, A02-II, A02-III, A02-IV, A03-I, A03-II, A03-III, A03-IV, B01-I, B01-II, B01-III, B01-IV, B02-I, B02-II, B02-III, B02-III, B02-IV, B03-I, B03-II, B03-III, B03-IV, STKY-DC01, STKY-DC02, STKY-DHL01, STKY-DHL02
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 | Number697656809HSB01RG | Date24 Jul 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- Withdrawn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 Hospital BedElectric Hospital Bed
- Model / Reference
- A01-I, A01-II, A01-III, A01-IV, A02-I, A02-II, A02-III, A02-IV, A03-I, A03-II, A03-III, A03-IV, B01-I, B01-II, B01-III, B01-IV, B02-I, B02-II, B02-III, B02-IV, B03-I, B03-II, B03-III, B03-IV, STKY-DC01, STKY-DC02, STKY-DHL01, STKY-DHL02
- Primary DI / UDI-DI
- 06976568090057, 06976568090019
- Basic UDI-DI
- 697656809HSB01RG, 697656809EB01NZ
- EMDN Code
- V080602, V08060101
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000034587
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: 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