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Individo Lux 2403

by VOCO GmbH

Ref 2403

Individo Lux 2403 is a dental base plate (EU MDR Class IIa; FDA Class I; FDA product code EBH, Material, Impression Tray, Resin) made by VOCO GmbH, registered in EUDAMED on 30 Mar 2026 (Basic UDI-DI ++E22102050000000008U) and listed in FDA GUDID since 6 Jun 2019 (UDI-DI E22124031), 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 Number++E22102050000000008U Basic UDI-DI E22124031UDI-DIDate30 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberE22124031 UDI-DI Date6 Jun 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++E22102050000000008U registered 30 Mar 2026 Active
  • FDA GUDID UDI-DI E22124031 listed 6 Jun 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID E22124031
  2. Registered EUDAMED ++E22102050000000008U

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  • Withdrawn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
Individo Lux
Generic name
Dental base plate
Model / Ref / Catalog
2403
Primary DI / UDI-DI
E22124031
Basic UDI-DI
++E22102050000000008U
FDA product code
EBH
EMDN code
Q010503 Impression material trays, single-use
GMDN term
Dental base plate
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3670
EU registration type
Standard device
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: Dental base plate

Similar devices in this category

Other devices filed under IMPRESSION MATERIAL TRAYS, SINGLE-USE.

Other devices from VOCO GmbH

See all devices from VOCO GmbH →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)