Rollator
by Foshan Zubon Technology Co., Ltd EUDAMED
Active
Ref ZBR008Model ZBR001, ZBR002, ZBR003, ZBR004, ZBR005, ZBR006, ZBR007, ZBR008, ZBR009, ZBR010, ZBR011, ZBR012, ZBR013, ZBR014, ZBR015, ZBR016, ZBR017, ZBR018, ZBR019, ZBR020, ZBR021, ZBR022, ZBR023, ZBR024, ZBR025, ZBR026, ZBR027, etc
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697360804ZBROR8 | Date6 Jan 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- ZBR001, ZBR002, ZBR003, ZBR004, ZBR005, ZBR006, ZBR007, ZBR008, ZBR009, ZBR010, ZBR011, ZBR012, ZBR013, ZBR014, ZBR015, ZBR016, ZBR017, ZBR018, ZBR019, ZBR020, ZBR021, ZBR022, ZBR023, ZBR024, ZBR025, ZBR026, ZBR027, etc
- Primary DI / UDI-DI
- 06973608040089
- Basic UDI-DI
- 697360804ZBROR8
- EMDN Code
- Y120606 Wheeled walker
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000045637
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Foshan Zubon 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