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Profibase 2114

by VOCO GmbH

Ref 2114

Profibase 2114 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 ++E2210207000000000AN) and listed in FDA GUDID since 6 Jun 2019 (UDI-DI E22121141), 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++E2210207000000000AN Basic UDI-DI E22121141UDI-DIDate30 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberE22121141 UDI-DI Date6 Jun 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++E2210207000000000AN registered 30 Mar 2026 Active
  • FDA GUDID UDI-DI E22121141 listed 6 Jun 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID E22121141
  2. Registered EUDAMED ++E2210207000000000AN

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  • Withdrawn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
Profibase
Generic name
Dental base plate
Model / Ref / Catalog
2114
Primary DI / UDI-DI
E22121141
Basic UDI-DI
++E2210207000000000AN
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)