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Galilei G6

by SIS AG, Surgical Instrument Systems

Ref 410.030.007Model Galilei G4, Galilei G6

Galilei G6 (410.030.007) is a device classified as Class IIa in the EU and Class II in the US made by SIS AG, Surgical Instrument Systems, registered in EUDAMED on 14 Apr 2026 (Basic UDI-DI 764016775CMSGALGK), cleared under FDA 510(k) K182659 on 25 Jul 2019 and listed in FDA GUDID since 20 Sep 2019 (UDI-DI 07640167751242), 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) K182659

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number764016775CMSGALGK Basic UDI-DI 07640167751242UDI-DIDate14 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07640167751242 UDI-DI Date20 Sep 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK182659 Date25 Jul 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 764016775CMSGALGK registered 14 Apr 2026 Active
  • FDA 510(k) K182659 decided 25 Jul 2019 Active
  • FDA GUDID UDI-DI 07640167751242 listed 20 Sep 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K182659
  2. Listed FDA GUDID 07640167751242
  3. Registered EUDAMED 764016775CMSGALGK

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  • Withdrawn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

Trade name
Galilei G6 EUDAMED
Galilei GUDID
Generic name
Optical low coherence reflectometry (OLCR) biometer
Model / Ref / Catalog
Galilei G4, Galilei G6, 410.030.007, G6
Primary DI / UDI-DI
07640167751242
Basic UDI-DI
764016775CMSGALGK
510(k) Number
FDA product code
MXK
EMDN code
Z12120102, Z12120123, Z12120199
GMDN term
Optical low coherence reflectometry (OLCR) biometer
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
886.1850
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Galilei G4, Galilei G6
410.030.007
GUDID
G6
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Eye anterior segment analyserOptical low coherence reflectometry (OLCR) biometerCorneal topography system application software

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Other devices filed under COMPUTERISED OPTICAL BIOMETERS.

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Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)