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Myopia Expert 700

by Visia imaging SRL

Ref BMT1IVModel MYAH; MYOPIA EXPERT 700510(k) K222933

Myopia Expert 700 (BMT1IV) is a medical device (EU MDR Class IIa; EMDN category computerised corneal topographs) made by Visia Imaging SRL, registered in EUDAMED on 9 May 2024 (Basic UDI-DI 803402877BIOMETER2C7) and cleared under FDA 510(k) K222933 on 29 Jun 2023 (1 earlier submission), active as of 22 Oct 2026.

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K222933↗

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803402877BIOMETER2C7 Basic UDI-DI 08034028770395UDI-DIDate9 May 2024RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK222933 Date29 Jun 2023IssuedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 803402877BIOMETER2C7 registered 9 May 2024 Active
  • FDA 510(k) K222933 decided 29 Jun 2023 Active· +1 more in the status table

Timeline

3 dated events

  1. Cleared FDA 510(k) K211868
  2. Cleared FDA 510(k) K222933
  3. Registered EUDAMED 803402877BIOMETER2C7

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Device name
Myah
Model / reference
MYAH, MYOPIA EXPERT 700, BMT1IV
Primary DI / UDI-DI
08034028770395
Basic UDI-DI
803402877BIOMETER2C7
EMDN code
Z12120123 Computerised corneal topographs
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000015628
FDA applicant
Visia Imaging S.R.L.

Similar devices in this category

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Properties

Other properties (14, all answered No)