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Topographic Modeling System TMS-4N

by Tomey Corporation

Ref TMS-4N

Topographic Modeling System TMS-4N is a corneal topography system (EU MDD Class IIa; FDA Class I; FDA product code MMQ, Topographer, Corneal, Ac-Powered) made by Tomey Corporation, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI B-04582273603714) and listed in FDA GUDID since 1 Apr 2022 (UDI-DI 04582273603714), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04582273603714 Basic UDI-DI 04582273603714UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04582273603714 UDI-DI Date1 Apr 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04582273603714 registered 7 Oct 2026 Active
  • FDA GUDID UDI-DI 04582273603714 listed 1 Apr 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04582273603714
  2. Registered EUDAMED B-04582273603714

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Topographic Modeling System
Generic name
Corneal topography system
Model / reference
TMS-4N
Primary DI / UDI-DI
04582273603714
Basic UDI-DI
B-04582273603714
FDA product code
MMQ
EMDN code
Z12120123 Computerised corneal topographs
GMDN term
Corneal topography system
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
886.1350
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
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: Corneal topography system

Other devices from Tomey Corporation

See all devices from Tomey Corporation →

Properties

  • Measuring function
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)