Identity
- Trade Name
- READING GLASSES/SION EUDAMED
- Device Name
- READING GLASSES EUDAMED
- Model / Reference
- FTRGL EUDAMEDFTSION1.50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05031720001652 EUDAMED
- Basic UDI-DI
- 5031720FTRGLQK EUDAMED
- EMDN Code
- Q0210030103 READY TO WEAR METAL AND PLASTIC SPECTACLES WITH ORGANIC LENSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Reading Glasses/Sion by Fortuna Healthcare Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5031720FTRGLQK | Class I | Active |
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Manufacturer
- Manufacturer
- Fortuna Healthcare Limited
- EUDAMED SRN
- UK-MF-000048072
- Authorised Representative
- Fortuna Healthcare (Ireland) Limited IE-AR-000044547
Sources (1)
- EUDAMED 6d2cee4b-a1e4-45e2-a816-66babfde1a7e 61 fields · synced Oct 6, 2026