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Synapsys VHIT Basic

by Inventis SRL

Ref 10738Model Synapsys VHIT

Synapsys VHIT Basic (10738) is a device classified as Class IIa in the EU and Class II in the US made by Inventis SRL, registered in EUDAMED on 8 May 2025 (Basic UDI-DI 805418738VHTPL) and listed in FDA GUDID since 8 Jan 2025 (UDI-DI 08054187380815), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805418738VHTPL Basic UDI-DI 08054187380815UDI-DIDate8 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08054187380815 UDI-DI Date8 Jan 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 805418738VHTPL registered 8 May 2025 Active
  • FDA GUDID UDI-DI 08054187380815 listed 8 Jan 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08054187380815
  2. Registered EUDAMED 805418738VHTPL

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  • Withdrawn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
Synapsys VHIT Basic EUDAMED
Synapsys VHIT GUDID
Generic name
Dynamic visual acuity testing system
Model / Ref / Catalog
Synapsys VHIT, 10738, Synapsys VHIT Basic
Primary DI / UDI-DI
08054187380815
Basic UDI-DI
805418738VHTPL
FDA product code
GWN
EMDN code
Z12140401 Vestibular assessment systems
GMDN term
Dynamic visual acuity testing system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.1460
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Synapsys VHIT
10738
GUDID
Synapsys VHIT Basic
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: Dynamic visual acuity testing system

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Properties

  • Measuring function
  • Prescription use
  • Serial number
Other properties (22, all answered No)