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Tracey-VFA Visual Function Analyzer iTrace

by Tracey Technologies

Ref Z2000Model iTrace

Tracey-VFA Visual Function Analyzer iTrace (Z2000) is a device classified as Class IIa in the EU and Class I in the US made by Tracey Technologies, registered in EUDAMED on 13 May 2026 (Basic UDI-DI 08604790017Z2000NN) and listed in FDA GUDID since 9 Jan 2020 (UDI-DI 00860479001706), 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
European UnionCE/MDR EUDAMED Number08604790017Z2000NN Basic UDI-DI 00860479001706UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00860479001706 UDI-DI Date9 Jan 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08604790017Z2000NN registered 13 May 2026 Active
  • FDA GUDID UDI-DI 00860479001706 listed 9 Jan 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00860479001706
  2. Registered EUDAMED 08604790017Z2000NN

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  • Withdrawn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
iTrace EUDAMED
Tracey-VFA Visual Function Analyzer GUDID
Generic name
Corneal topography system
Device name
Tracey VFA Visual Function Analyzer
Model / Ref / Catalog
iTrace, Z2000
Primary DI / UDI-DI
00860479001706
Basic UDI-DI
08604790017Z2000NN
Direct marketing DI
00860479001706
FDA product code
NCF
EMDN code
Q0299, V030203
GMDN term
Corneal topography system
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
886.1760
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
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Automated ophthalmic refractometerCorneal topography system

Similar devices in this category

Other devices filed under OPHTHALMOLOGY MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES.

Properties

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