Rollator
by Shanghai Humancare Industries Co., Ltd 76 variants
Ref HC0561DModel HC0504P HC0503L HC0514 HC0541L HC0561L HC0573 HC0573F HC0574L HC0576 HC0580 HC0509 HC0521W HC0512L HC0502 HC0582 HC0551L HC0561L-1 HC0562L HC0563L HC0564L HC0565L HC0508L HC0588 HC0591L HC0592 HC0594 HC0510L HC0510L-4 HC0510LD-5 HC0512L-1 HC0514LG ,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 | Number697480946Rollator0001ZK 06974809463691 | Date6 Jul 2023 | 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- Withdrawn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
- Rollator
- Model / Reference
- HC0504P HC0503L HC0514 HC0541L HC0561L HC0573 HC0573F HC0574L HC0576 HC0580 HC0509 HC0521W HC0512L HC0502 HC0582 HC0551L HC0561L-1 HC0562L HC0563L HC0564L HC0565L HC0508L HC0588 HC0591L HC0592 HC0594 HC0510L HC0510L-4 HC0510LD-5 HC0512L-1 HC0514LG, etc, HC0561D
- Primary DI / UDI-DI
- 06974809463691
- Basic UDI-DI
- 697480946Rollator0001ZK
- Direct Marketing DI
- 06974809463691
- EMDN Code
- Y120606 Wheeled walker
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000009765
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shanghai Humancare Industries Co., Ltd
See all devices from Shanghai Humancare Industries 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