Electric Wheelchair
by Bazhou Shengkun Medical Device Co., Ltd. 7 variants
Ref SK-100-W02Model SK-100-W01; SK-100-W02; SK-100-W03; SK-100-W04; SK-100-W05; SK-100-W06; SK-100-W07
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 | Number697913446SKEWU7 06979134460025 | Date23 Sep 2025 | 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- Withdrawn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
- Model / Reference
- SK-100-W01, SK-100-W02, SK-100-W03, SK-100-W04, SK-100-W05, SK-100-W06, SK-100-W07
- Primary DI / UDI-DI
- 06979134460025
- Basic UDI-DI
- 697913446SKEWU7
- EMDN Code
- Y122127 Electric wheelchairs
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000049634
- Authorised representative
- HyperCert Limited B.V. NL-AR-000047746
Other devices from Bazhou Shengkun 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