Mobility Scooter
by Zhejiang Tongda Electric Appliance Co., Ltd
Ref A0Model A0,A1,A2,A3,A4,A5,A6,A7,A8,A9,A10,A11,A12,A13,A14,A15,A16,BO,B1,B2,B3,B4,B5,B6,B7
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 | Number697822855MS01RC | Date27 Jan 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- Withdrawn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
- Device Name
- Mobility Scooter
- Model / Reference
- A0, A1, A2, A3, A4, A5, A6, A7, A8, A9, A10, A11, A12, A13, A14, A15, A16, BO, B1, B2, B3, B4, B5, B6, B7
- Primary DI / UDI-DI
- 06978228550000
- Basic UDI-DI
- 697822855MS01RC
- EMDN Code
- Y122124 Electric scooters
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000045995
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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