Robooter E40
by Shanghai Bangbang Robotics Co., Ltd. 8 variants
Ref BBR-E40sModel BBR-E40-01
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 | Number697484214E40PM | Date18 Sep 2024 | 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- Withdrawn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(Robooter E40)
- Model / Reference
- BBR-E40-01, BBR-E40s
- Primary DI / UDI-DI
- 06974842141389, 06974842141778, 06974842141938
- Basic UDI-DI
- 697484214E40PM
- Direct Marketing DI
- 0697484214177806974842141938
- EMDN Code
- Y122127 Electric wheelchairs
- Device Class
- Class I
- EU market of registration
- TürkiyeItalySpain
Manufacturer details
- EUDAMED SRN
- CN-MF-000028321
- Authorised representative
- Kingsmead Service B.V. NL-AR-000002066
Other devices from Shanghai Bangbang Robotics 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