Electric Wheelchairs
by Zhejiang Lumbre Electric Appliance Co., Ltd. EUDAMED
Active
Ref DY612A-1, DY611A-2Model DY612A-1,DY611A-2
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697638506EW001KA | Date19 Aug 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Electric Wheelchairs
- Model / Reference
- DY612A-1, DY611A-2
- Primary DI / UDI-DI
- 06976385060011, 06976385060028
- Basic UDI-DI
- 697638506EW001KA
- EMDN Code
- Y122127 Electric wheelchairs
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000049163
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Zhejiang Lumbre Electric Appliance 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