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SOLOS Lite

by Visia imaging SRL

Ref 42-0002770Model SOLOS; SOLOS Lite

SOLOS Lite (42-0002770) is an automated lensmeter (EU MDR Class I; FDA Class I; FDA product code HLM, Instrument, Measuring, Lens, Ac-Powered) made by Visia Imaging SRL, registered in EUDAMED on 12 Jul 2022 (Basic UDI-DI 803402877LENSMETER1CX) and listed in FDA GUDID since 20 Feb 2025 (UDI-DI 08034028770524), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08034028770524 UDI-DI Date20 Feb 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number803402877LENSMETER1CX Basic UDI-DI 08034028770524UDI-DIDate12 Jul 2022RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 803402877LENSMETER1CX registered 12 Jul 2022 Active
  • FDA GUDID UDI-DI 08034028770524 listed 20 Feb 2025 Listed

Timeline

2 dated events

  1. Registered EUDAMED 803402877LENSMETER1CX
  2. Listed FDA GUDID 08034028770524

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
SOLOS Lite EUDAMED
Topcon GUDID
Generic name
Automated lensmeter
Device name
Solos
Model / Ref / Catalog
SOLOS, SOLOS Lite, 42-0002770
Primary DI / UDI-DI
08034028770524
Basic UDI-DI
803402877LENSMETER1CX
FDA product code
HLM
EMDN code
Z12120199 Ophtalmology assessments and diagnosis instruments – other
GMDN term
Automated lensmeter
Device class
Class I
Regulation number
886.1425
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
SOLOS; SOLOS Lite
42-0002770
GUDID
SOLOS LITE

Manufacturer details

EUDAMED SRN
IT-MF-000015628

Similar devices in this category

Other devices filed under OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER.

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Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (22, all answered No)