Electric wheelchair
by Zhejiang Ever Well Electric Appliance Group Co., Ltd 6 variants
Ref EF-SW1-12BLModel EF-SW1-12B, EF-SN1-12B EF-SW1-16B, EF-SN1-16B EF-SW1-12BL, EF-SN1-12BL EF-SW1-16BL, EF-SN1-16BL EF-SW2-12B, EF-SN2-12B
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 | Number697652468EW001L7 06976524680209 | Date6 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- Withdrawn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
- Electric wheelchair
- Model / Reference
- EF-SW1-12B, EF-SN1-12B EF-SW1-16B, EF-SN1-16B EF-SW1-12BL, EF-SN1-12BL EF-SW1-16BL, EF-SN1-16BL EF-SW2-12B, EF-SN2-12B, EF-SW1-12BL
- Primary DI / UDI-DI
- 06976524680209
- Basic UDI-DI
- 697652468EW001L7
- Direct Marketing DI
- 06976524680209
- EMDN Code
- Y122127 Electric wheelchairs
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000036374
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Zhejiang Ever Well Electric Appliance Group 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