Ultralight Flip-up loupes
Ref 10131Model Optical Ergonomic Solutions
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 | Number735015282GaliFUPPriSpecZM | Date26 May 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- Withdrawn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
- Model / Reference
- Optical Ergonomic Solutions, 10131
- Primary DI / UDI-DI
- 07350152820364, 07350152820227, 07350152820234, 07350152820289, 07350152820333, 07350152820296, 07350152820265, 07350152820173, 07350152820340, 07350152820180, 07350152820166, 07350152820272, 07350152820302, 07350152820319, 07350152820357, 07350152820371, 07350152820159
- Basic UDI-DI
- 735015282GaliFUPPriSpecZM, 735015282GaliFUPProSpec3S
- EMDN Code
- Q0299 Ophthalmic devices - other
- Device Class
- Class I
- EU market of registration
- Sweden
Manufacturer details
- EUDAMED SRN
- SE-MF-000032762
Other devices from Optergo AB
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