Rollator
by Foshan Zubon Technology Co., Ltd 189 variants
Ref ZBR089Model 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
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 | Number697360804ZBROR8 | Date6 Jan 2025 | StatusActive |
Certificates
No notified-body 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- Withdrawn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
- 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, ZBR089
- Primary DI / UDI-DI
- 06973608040898
- 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