Skip to content

Trios® 4 S3A-18

by 3Shape TRIOS A/S

Ref S3A-18

Trios 4 S3A-18, an intraoral optical scanning system (EU MDR Class I; FDA Class II; FDA product code NOF) made by 3Shape TRIOS A/S, was registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 590272975009F8) and listed in FDA GUDID on 21 May 2019 (UDI-DI 05902729753012); the registry lists it as withdrawn as of 7 Nov 2026.

Withdrawn Withdrawn in European Union.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number590272975009F8 Basic UDI-DI 05902729753012UDI-DIDate26 Oct 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number05902729753012 UDI-DI Date21 May 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 590272975009F8 registered 26 Oct 2026 Withdrawn
  • FDA GUDID UDI-DI 05902729753012 listed 21 May 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05902729753012
  2. Registered EUDAMED 590272975009F8

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDR Withdrawn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

Specification

EUDAMED · GUDID

Trade name
3Shape EUDAMED
Trios® 4 GUDID
Generic name
Intraoral optical scanning system
Device name
Trios 4
Model / reference
S3A-18
Primary DI / UDI-DI
05902729753012
Basic UDI-DI
590272975009F8
FDA product code
NOF
EMDN code
Q0199 Odontology devices - other
GMDN term
Intraoral optical scanning system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.3661
EU registration type
Standard device
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Intraoral optical scanning system

Similar devices in this category

Other devices filed under ODONTOLOGY DEVICES - OTHER.

Other devices from 3Shape TRIOS A/S

  • 3Shape

    Class I

  • Trios Move Pro C4.2

    Class II

  • TRIOS Dx R1.1

    Class II

  • TRIOS Dx R1.2

    Class II

See all devices from 3Shape TRIOS A/S →

Properties

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