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Trios 6 L1P-2

by 3Shape TRIOS A/S

Ref L1P-2

Trios 6 L1P-2 is an intraoral optical scanning system (EU MDR Class IIa; FDA Class II; FDA product code NOF) made by 3Shape TRIOS A/S, registered in EUDAMED on 21 Sep 2026 (Basic UDI-DI 590272975019FB) and listed in FDA GUDID since 24 Apr 2025 (UDI-DI 05902729753982), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number590272975019FB Basic UDI-DI 05902729753982UDI-DIDate21 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05902729753982 UDI-DI Date24 Apr 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 590272975019FB registered 21 Sep 2026 Active
  • FDA GUDID UDI-DI 05902729753982 listed 24 Apr 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05902729753982
  2. Registered EUDAMED 590272975019FB

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  • Withdrawn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
3Shape EUDAMED
Trios 6 GUDID
Generic name
Intraoral optical scanning system
Model / reference
L1P-2
Primary DI / UDI-DI
05902729753982
Basic UDI-DI
590272975019FB
FDA product code
NOF
EMDN code
Q0199 Odontology devices - other
GMDN term
Intraoral optical scanning system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3661
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: 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)