Lower Limb Brace
by Anping Yikang Medical Instrument Co., Ltd EUDAMED
Active
Ref G116Model F101 F102 F103 F103-1 F103-2 F104 F104-1 F104-2 F104-3 F104-4 F105 F105-1 F105-2 F105-3 F105-4 F106 F106-1 F106-2 F107 F108 F108-1 F109 F110 F111 F112 F113 F114 F115 F201 F202 F203 F203-1 F203-2 F203-3 F203-4 F204 F204-1 F204-2 F204-3 F204-4 F205 etc
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697428637LLB01MP | Date13 Jan 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- Lower Limb Brace
- Model / Reference
- F101 F102 F103 F103-1 F103-2 F104 F104-1 F104-2 F104-3 F104-4 F105 F105-1 F105-2 F105-3 F105-4 F106 F106-1 F106-2 F107 F108 F108-1 F109 F110 F111 F112 F113 F114 F115 F201 F202 F203 F203-1 F203-2 F203-3 F203-4 F204 F204-1 F204-2 F204-3 F204-4 F205 etc, G116
- Primary DI / UDI-DI
- 06974286371946
- Basic UDI-DI
- 697428637LLB01MP
- EMDN Code
- Y06120601 Passive ankle-foot orthoses
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000045899
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Anping Yikang Medical Instrument Co., Ltd
See all devices from Anping Yikang Medical Instrument 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