Identity
- Trade Name
- SOLOS EUDAMEDTOPCON FDA UDI
- Generic Name
- Automated lensmeter FDA UDI
- Device Name
- SOLOS EUDAMEDinstrument intended for use by an optometric/ ophthalmic professional to measure spectacles and single lens properties. FDA UDI
- Model / Reference
- SOLOS; SOLOS Lite EUDAMED42-0001417 EUDAMEDSOLOS FDA UDI
- Description
- instrument intended for use by an optometric/ ophthalmic professional to measure spectacles and single lens properties. FDA UDI
Identifiers
- Catalog Number
- 42-0001417 FDA UDI
- Primary DI / UDI-DI
- 08034028770401 EUDAMEDFDA UDI
- Basic UDI-DI
- 803402877LENSMETER1CX EUDAMED
- FDA Product Code
- HLM FDA UDI
- EMDN Code
- Z12129099 VARIOUS OPHTALMOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Automated lensmeter FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1425 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Solos by Visia Imaging Srl — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803402877LENSMETER1CX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Visia imaging SRL
- EUDAMED SRN
- IT-MF-000015628
Sources (2)
- EUDAMED 55d3cda7-0d8e-48e6-977c-a04e7c521164 61 fields · synced Jun 19, 2026
- FDA UDI dcfa266c-66d6-496e-835d-2ac9d7b6899b 34 fields · synced May 30, 2026