FR08
by Suzhou Flyer Medical Technology Company Limited EUDAMED
Active
Ref FR08Model FRR01, FRR02, FRR03, FRR04, FRR05, FRR06, FRR07, FRR08, FRR09, FRR10, FRR11, FRR12, FRR13, FRR14, FRR15, FRR16, FRR17, FRR18, FRR19, FRR20, FRR21, FRR22, FRR23, FRR24, FRR25
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697759994ROL0146 | Date10 Jul 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Rollator
- Model / Reference
- FRR01, FRR02, FRR03, FRR04, FRR05, FRR06, FRR07, FRR08, FRR09, FRR10, FRR11, FRR12, FRR13, FRR14, FRR15, FRR16, FRR17, FRR18, FRR19, FRR20, FRR21, FRR22, FRR23, FRR24, FRR25, FR08
- Primary DI / UDI-DI
- 06977599940083
- Basic UDI-DI
- 697759994ROL0146
- Direct Marketing DI
- 06977599940083
- EMDN Code
- Y122127 Electric wheelchairs
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000042599
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Suzhou Flyer Medical Technology Company Limited
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