Mobility Scooter
by Xuzhou Heabens Medical Technology Co., LTD.
Ref DB01, DB21, DB02, DB22Model DB01; DB02; DB03; DB04; DB05; DB21; DB22; DB23; KD1; KD1-L; KD1-S
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 | Number697521376escooterJK | Date27 Apr 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- Withdrawn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
- DB01, DB02, DB03, DB04, DB05, DB21, DB22, DB23, KD1, KD1-L, KD1-S
- Primary DI / UDI-DI
- 06975213760093, 06975213760109, 06975213760383, 06975213760390
- Basic UDI-DI
- 697521376escooterJK
- EMDN Code
- Y122124 Electric scooters
- Device Class
- Class I
- EU market of registration
- GermanyAustria
Manufacturer details
- EUDAMED SRN
- CN-MF-000031737
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Xuzhou Heabens Medical Technology Co., LTD.
See all devices from Xuzhou Heabens Medical Technology 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