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Celalux III 9091

by VOCO GmbH

Ref 9091

Celalux III 9091 is a dental/surgical polymerization lamp (EU MDR Class I; FDA Class II; FDA product code EBZ, Activator, Ultraviolet, For Polymerization) made by VOCO GmbH, registered in EUDAMED on 30 Mar 2026 (Basic UDI-DI ++E2210908000000000KN) and listed in FDA GUDID since 31 Aug 2016 (UDI-DI E22190911), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E2210908000000000KN Basic UDI-DI E22190911UDI-DIDate30 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberE22190911 UDI-DI Date31 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++E2210908000000000KN registered 30 Mar 2026 Active
  • FDA GUDID UDI-DI E22190911 listed 31 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID E22190911
  2. Registered EUDAMED ++E2210908000000000KN

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  • Withdrawn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
Celalux III
Generic name
Dental/surgical polymerization lamp
Model / Ref / Catalog
9091
Primary DI / UDI-DI
E22190911
Basic UDI-DI
++E2210908000000000KN
FDA product code
EBZ
EMDN code
Z12119003 Cold light dental equipment
GMDN term
Dental/surgical polymerization lamp
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.6070
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 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: Dental/surgical polymerization lamp

Similar devices in this category

Other devices filed under VARIOUS DENTAL STOMATOLOGY INSTRUMENTS.

Other devices from VOCO GmbH

See all devices from VOCO GmbH →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)