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QbCheck

by Qbtech AB

510(k) K143468Ref 07350103930012

QbCheck is a device classified as Class I (EU), Unclassified (US) made by Qbtech AB, registered in EUDAMED on 20 May 2026 (Basic UDI-DI B-07350103930012), cleared under FDA 510(k) K143468 on 22 Mar 2016 and listed in FDA GUDID since 14 Jun 2023 (UDI-DI 07350103930012), active as of 7 Nov 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K143468↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07350103930012 Basic UDI-DI 07350103930012UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07350103930012 UDI-DI Date14 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK143468 Date22 Mar 2016ClearedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07350103930012 registered 20 May 2026 Active
  • FDA 510(k) K143468 decided 22 Mar 2016 Active
  • FDA GUDID UDI-DI 07350103930012 listed 14 Jun 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K143468
  2. Listed FDA GUDID 07350103930012
  3. Registered EUDAMED B-07350103930012

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic name
Psychological assessment software
Model / reference
07350103930012 EUDAMED
QbCheck GUDID
Primary DI / UDI-DI
07350103930012
Basic UDI-DI
B-07350103930012
510(k) Number
FDA product code
LQD
EMDN code
V92 Medical device software - not included in other classes
GMDN term
Psychological assessment software
Device class
Class I EUDAMED
U 510(k)GUDID
EU registration type
Legacy device (under a directive)
EU market of registration
Sweden
Advisory committee
Unknown
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
Model / referenceEUDAMED
07350103930012
510(k)
—
GUDID
QbCheck
Device classEUDAMED
Class I
510(k)
U
GUDID
U

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), U in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K143468

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K143468
UDI-DISize and differences
QbCheck
Qbtech Inc
QbCheck07350103930012 —On the market

Similar devices in this category

Other devices filed under MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES.

Other devices from Qbtech Inc

  • QbTest

    Unclassified

  • Qb Test

    Unclassified

  • Qbtes

    Unclassified

  • Qbtest

    Unclassified

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)