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Myopia Expert 700

by Visia Imaging SRL

Myopia Expert 700 (BMT00004) is a Class II device made by Visia Imaging SRL, cleared under FDA 510(k) K211868 on 1 Mar 2022, registered in EUDAMED and listed in FDA GUDID since 22 Jun 2022 (UDI-DI 08034028770463), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211868

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08034028770463 UDI-DI Date22 Jun 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK211868 Date1 Mar 2022IssuedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K211868 decided 1 Mar 2022 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 08034028770463 listed 22 Jun 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K211868
  2. Listed FDA GUDID 08034028770463

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Corneal topography system
Model / Ref / Catalog
MYOPIA EXPERT 700, BMT00004
Primary DI / UDI-DI
08034028770463
510(k) Number
FDA product code
MXK
GMDN term
Corneal topography system
Device class
Class II
Regulation number
886.1850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Corneal topography system

Cleared under the same submission (K211868)

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See all devices from Visia Imaging SRL →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)