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Reading Glasses Orlando 4.00
EUDAMEDClass I (EU MDR)
Ref FT25ORLANDO4.00Model FTRGL
Identity
- Trade Name
- READING GLASSES ORLANDO 4.00 EUDAMED
- Device Name
- READING GLASSES EUDAMED
- Model / Reference
- FTRGL EUDAMEDFT25ORLANDO4.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05031720054771 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 Orlando 4.00 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 ddf7a281-662e-483e-b969-0666ad60c257 61 fields · synced Oct 6, 2026