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Quick Up

by VOCO GmbH

Ref 1625

Quick Up (1625) 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 ++E2210363000000000DZ), cleared under FDA 510(k) K110440 on 4 May 2011 (1 earlier submission) and listed in FDA GUDID since 15 Sep 2017 (UDI-DI E22116251), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K110440↗

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E2210363000000000DZ Basic UDI-DI E22116251UDI-DIDate30 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberE22116251 UDI-DI Date15 Sep 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK110440 Date4 May 2011IssuedStatusActive
United StatesFDA 510(k) GUDID from GUDID NumberK110050 Date28 Mar 2011IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++E2210363000000000DZ registered 30 Mar 2026 Active
  • FDA 510(k) K110440 decided 4 May 2011 Active· +1 more in the status table
  • FDA GUDID UDI-DI E22116251 listed 15 Sep 2017 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K110050
  2. Cleared FDA 510(k) K110440
  3. Listed FDA GUDID E22116251
  4. Registered EUDAMED ++E2210363000000000DZ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade name
Quick Up EUDAMED
Quick Up LC GUDID
Generic name
Silicone dental impression material
Model / Ref / Catalog
1625
Primary DI / UDI-DI
E22116251
Basic UDI-DI
++E2210363000000000DZ
510(k) Number
FDA product code
ELW, EBI
EMDN code
Q01020601 Mobile dental prostheses
GMDN term
Silicone dental impression material
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3660, 872.3760
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 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.

Manufacturer details

EUDAMED SRN
DE-MF-000008601

Related devices

Category: Partial denture

Similar devices in this category

Other devices filed under MOBILE DENTAL PROSTHESES.

Other devices from VOCO GmbH

See all devices from VOCO GmbH →

Properties

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