Pedal Exerciser
by Foshan Shunkangda Medical Tech Co., Ltd 7 variants
Ref CA2314Model CA231,CA2312,CA2312-A,CA2312-B, CA2313,CA2314,CA2315, CA2316
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 | Number697222325140001KJ 06972223257551 | Date25 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- Withdrawn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
- Pedal Exerciser
- Model / Reference
- CA231, CA2312, CA2312-A, CA2312-B, CA2313, CA2314, CA2315, CA2316
- Primary DI / UDI-DI
- 06972223257551
- Basic UDI-DI
- 697222325140001KJ
- EMDN Code
- Y0504 Arms, torso and legs re-education devices
- Device Class
- Class I
- EU market of registration
- Slovenia
Manufacturer details
- EUDAMED SRN
- CN-MF-000008483
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Foshan Shunkangda Medical Tech Co., Ltd
See all devices from Foshan Shunkangda Medical Tech 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