Aisoleij
by Nanjing Aishun Green Technology Co., Ltd 4 variants
Ref M6005, M6018, M6011, DB08, K03Model M6000, DB11L, L26M, XLiDR-3L, DB10, AFD2D-4L
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 | Number697648500EWAUZ | Date19 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- Withdrawn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 WheelchairMobility Scooter
- Model / Reference
- M6000, M6005, DB11L, L26M, XLiDR-3L, M6018, M6011, DB10, DB08, AFD2D-4L, K03
- Primary DI / UDI-DI
- 06976485000085, 06976485000054, 06976485000177, 06976485000030, 06976485000122, 06976485000108, 06976485000252, 06976485000047, 06976485000078
- Basic UDI-DI
- 697648500EWAUZ, 697648500EMDB11LQT, 697648500L26ML8, 697648500XLIDR3L9X, 697648500EMSV7, 697648500AFD2D4LKN
- EMDN Code
- Y122127, Y122124
- Device Class
- Class I
- EU market of registration
- FranceSwedenPolandAustriaLatviaGreece
Manufacturer details
- EUDAMED SRN
- CN-MF-000040810
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Other devices from Nanjing Aishun Green Technology Co., Ltd
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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