Spectacle Frames
by Wenzhou Higo Optical Co., Ltd EUDAMED
Active
Ref HTM-2004Model CH7921,CH7930,SF-M002,SF-M001,SF-M003, HTM-2003,OB1023,RD26014,RD26060,HTM-2004, HTM2010,F5796LT,F5797LT,CH7917,OLD25074T,OLD25161T,OB1001 CH6804,25305,HTM-2015,HTM-2015,HTM-2017,PYT2700,PYT2712, PYT2715, from PYT2718 to PYT2725,PYT2727
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697473781RS3XB | Date9 Mar 2026 | 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- Withdrawn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
- CH7921, CH7930, SF-M002, SF-M001, SF-M003, HTM-2003, OB1023, RD26014, RD26060, HTM-2004, HTM2010, F5796LT, F5797LT, CH7917, OLD25074T, OLD25161T, OB1001 CH6804, 25305, HTM-2015, HTM-2017, PYT2700, PYT2712, PYT2715, from PYT2718 to PYT2725, PYT2727
- Primary DI / UDI-DI
- 06974737810277
- Basic UDI-DI
- 697473781RS3XB
- EMDN Code
- Q02100201,Q02100202,Q02100203,Q02100299
- Device Class
- Class I
- Market of Registration
- Latvia
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