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SOLOS Lite
EUDAMEDFDA UDIClass I (EU MDR)
Ref 42-0002770Model SOLOS; SOLOS Lite
Identity
- Trade Name
- SOLOS Lite EUDAMEDTOPCON FDA UDI
- Generic Name
- Automated lensmeter FDA UDI
- Device Name
- SOLOS EUDAMEDSOLOS Lite is an instrument intended for use by an optometric/ ophthalmic professional to monitor the visual defects through the measurements of spectacles and single lens optical properties FDA UDI
- Model / Reference
- SOLOS; SOLOS Lite EUDAMED42-0002770 EUDAMEDSOLOS LITE FDA UDI
- Description
- SOLOS Lite is an instrument intended for use by an optometric/ ophthalmic professional to monitor the visual defects through the measurements of spectacles and single lens optical properties FDA UDI
Identifiers
- Catalog Number
- 42-0002770 FDA UDI
- Primary DI / UDI-DI
- 08034028770524 EUDAMEDFDA UDI
- Basic UDI-DI
- 803402877LENSMETER1CX EUDAMED
- FDA Product Code
- HLM FDA UDI
- EMDN Code
- Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS 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 Lite 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 6ce84f9d-722b-4183-9721-722c858be19d 61 fields · synced Jun 18, 2026
- FDA UDI 312332a2-eb30-4bd5-a654-7d2dc3bf93f2 34 fields · synced May 27, 2026