Spectacle Frames
by Wenzhou Higo Optical Co., Ltd EUDAMED
Active
Ref HG6107-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
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697473781HG001JB | Date10 Apr 2024 | 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- Withdrawn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
- 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, HG6107-C3
- Primary DI / UDI-DI
- 06974737817405
- Basic UDI-DI
- 697473781HG001JB
- EMDN Code
- Q02100201,Q02100202,Q02100203,Q02100299
- Device Class
- Class I
- 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