Electric Wheelchair
by Zhejiang Kairui Medical Device Co., Ltd 4 variants
Ref KR8810Model KR8803 KR8807 KR8809 KR8810 KR8811 KR007 M4000 M5000 K01 K02 KR8812 K05 K06 KR03 KR07 K03 K04 K07 K08 M6000
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 | Number697729041KREWS6 06977290410120 | Date28 Mar 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- Withdrawn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
- KR8803 KR8807 KR8809 KR8810 KR8811 KR007 M4000 M5000 K01 K02 KR8812 K05 K06 KR03 KR07 K03 K04 K07 K08 M6000, KR8810
- Primary DI / UDI-DI
- 06977290410120
- Basic UDI-DI
- 697729041KREWS6
- EMDN Code
- Y122127 Electric wheelchairs
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000010955
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Zhejiang Kairui Medical Device Co., Ltd.
See all devices from Zhejiang Kairui Medical Device 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