Robooter E80
by Jiangsu Bangbang Intelligent Technology Co., Ltd. 6 variants
Ref BBR-E80-02Model X40, E40,E40s, E40AA1, E60, E80, C40, C60, F20, P60, P80
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 | Number697824658EW6E | Date26 Feb 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- Withdrawn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
- Electric wheelchair
- Model / Reference
- X40, E40, E40s, E40AA1, E60, E80, C40, C60, F20, P60, P80, BBR-E80-02
- Primary DI / UDI-DI
- 06978246580058, 06978246580508, 06978246580898
- Basic UDI-DI
- 697824658EW6E
- Direct Marketing DI
- 069782465800580697824658050806978246580898
- EMDN Code
- Y122127 Electric wheelchairs
- Device Class
- Class I
- EU market of registration
- IrelandFrance
Manufacturer details
- EUDAMED SRN
- CN-MF-000046169
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Jiangsu Bangbang Intelligent Technology Co., Ltd.
See all devices from Jiangsu Bangbang Intelligent 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