Spectacle Frames
by Wenzhou Higo Optical Co., Ltd 654 variants
Ref TTR-C9059-C3Model HG5810, HG5811, HG5812, HG5813, HG5814, HG5815, HG5816, HG5817, HG5818, HG5819, HG5820, HG5821, HG5822, HG5823, HG5824, HG5825, HG5826, HG5827, HG5828, HG5829, HG5830, HG5831, HG5832, HG5833, HG5834, HG5835, HG5836, HG5837, HG5838, HG5839, etc
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 | Number697473781HG001JB 06974737817207 | Date10 Apr 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- Withdrawn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
- Device Name
- Spectacle Frames
- Model / Reference
- HG5810, HG5811, HG5812, HG5813, HG5814, HG5815, HG5816, HG5817, HG5818, HG5819, HG5820, HG5821, HG5822, HG5823, HG5824, HG5825, HG5826, HG5827, HG5828, HG5829, HG5830, HG5831, HG5832, HG5833, HG5834, HG5835, HG5836, HG5837, HG5838, HG5839, etc, TTR-C9059-C3
- Primary DI / UDI-DI
- 06974737817207
- Basic UDI-DI
- 697473781HG001JB
- EMDN Code
- Q02100201, Q02100202, Q02100203, Q02100299
- Device Class
- Class I
- EU market of registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CN-MF-000022737
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Wenzhou Higo Optical 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