Insole
by Dongguan Jiuhui Industrial Limited 469 variants
Model JHZ4-003
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 | Number697642557in28733 06976425572870 | Date20 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- Withdrawn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
- JHZ4-003
- Primary DI / UDI-DI
- 06976425572870
- Basic UDI-DI
- 697642557in28733
- EMDN Code
- Y061203 Orthoses, foot (including insoles and inserts)
- Device Class
- Class I
- EU market of registration
- Austria
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