Insole
by Dongguan Jiuhui Industrial Limited 469 variants
Model JH-20913
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
The INSOLE medical device is a Class I device designed for the placement of endoscopic instruments, offering precise and accurate placement of sutures. Developed in Dongguan Jiuhui Industrial Limited, this implantable device has undergone rigorous testing to ensure its safety and efficacy.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697642557in021ZQ 06976425570210 | Date22 Apr 2026 | 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- Withdrawn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
- Insole
- Model / Reference
- JH-20913
- Primary DI / UDI-DI
- 06976425570210
- Basic UDI-DI
- 697642557in021ZQ
- EMDN Code
- Y061203 Orthoses, foot (including insoles and inserts)
- Device Class
- Class I
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CN-MF-000035646
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Dongguan Jiuhui Industrial Limited
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