Lower-limb Walking Assistance Device
by Yrobot (Suzhou) Co., Ltd. 6 variants
Ref Rego Health -ANK-1SS, Rego Health -ANK-1SM, Relink-ANK-1BXXXS, Relink-ANK-1BSModel Rego Health-ANK-1S series, Relink-ANK-1B series
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 | Number697345831RH001HN | Date1 Feb 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- Withdrawn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
- Model / Reference
- Rego Health-ANK-1S series, Rego Health -ANK-1SS, Rego Health -ANK-1SM, Relink-ANK-1B series, Relink-ANK-1BXXXS, Relink-ANK-1BS
- Primary DI / UDI-DI
- 06973458310202, 06973458310196, 06973458310172, 06973458310141
- Basic UDI-DI
- 697345831RH001HN, 697345831RL001JJ
- Direct Marketing DI
- 06973458310202069734583101960697345831017206973458310141
- EMDN Code
- Z12069002 Assisted locomotion systems
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000038890
- Authorised representative
- MedPath GmbH DE-AR-000000087
Other devices from Yrobot (Suzhou) 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