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IonoStar Plus 2543

by VOCO GmbH

Ref 2543

IonoStar Plus 2543 is a device classified as Class IIa in the EU and Class II in the US made by VOCO GmbH, registered in EUDAMED on 30 Mar 2026 (Basic UDI-DI ++E221021200000000074) and listed in FDA GUDID since 13 Sep 2016 (UDI-DI E22125431), 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++E221021200000000074 Basic UDI-DI E22125431UDI-DIDate30 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberE22125431 UDI-DI Date13 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++E221021200000000074 registered 30 Mar 2026 Active
  • FDA GUDID UDI-DI E22125431 listed 13 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID E22125431
  2. Registered EUDAMED ++E221021200000000074

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  • Withdrawn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
IonoStar Plus
Generic name
Glass ionomer dental cement
Model / Ref / Catalog
2543
Primary DI / UDI-DI
E22125431
Basic UDI-DI
++E221021200000000074
FDA product code
EMA
EMDN code
Q01010106 Dental restoration glass ionomers
GMDN term
Glass ionomer dental cement
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3275
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

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: Glass ionomer dental cement

Similar devices in this category

Other devices filed under DENTAL RESTORATION GLASS IONOMERS.

Other devices from VOCO GmbH

See all devices from VOCO GmbH →

Properties

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