Fortuna
by Fortuna Healthcare Limited EUDAMED
Active
Ref FT-1370Model FTRGL
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5031720FTRGLQK | Date27 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- Reading Glasses
- Model / Reference
- FTRGL, FT-1370
- Primary DI / UDI-DI
- 05031720031789
- Basic UDI-DI
- 5031720FTRGLQK
- EMDN Code
- Q0210030101 Ready to wear metal spectacles with organic lenses
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- UK-MF-000048072
- Authorised representative
- Fortuna Healthcare (Ireland) Limited IE-AR-000044547
Other devices from Fortuna Healthcare 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