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Qbc Star

by Drucker Diagnostics

Ref 429001

Qbc Star (429001) is a device classified as IVD General (EU), Class II (US) made by Drucker Diagnostics, registered in EUDAMED on 4 Feb 2025 (Basic UDI-DI B-00858092006000), cleared under FDA 510(k) K992849 on 23 Sep 1999 and listed in FDA GUDID since 31 Aug 2016 (UDI-DI 00858092006000), active as of 22 Oct 2026.

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

CE IVDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K992849

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00858092006000 Basic UDI-DI 00858092006000UDI-DIDate4 Feb 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00858092006000 UDI-DI Date31 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK992849 Date23 Sep 1999DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00858092006000 registered 4 Feb 2025 Active
  • FDA 510(k) K992849 decided 23 Sep 1999 Active
  • FDA GUDID UDI-DI 00858092006000 listed 31 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K992849
  2. Listed FDA GUDID 00858092006000
  3. Registered EUDAMED B-00858092006000

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
QBC Diagnostics
Generic name
Full blood count IVD, kit, cell count
Model / Ref / Catalog
429001
Primary DI / UDI-DI
00858092006000
Basic UDI-DI
B-00858092006000
510(k) Number
FDA product code
GKZ
EMDN code
W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
GMDN term
Full blood count IVD, kit, cell count
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
864.5220
EU registration type
Legacy device (under a directive)
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class II

Device class is stated on each registry's own scale: Class IVD General 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
US-MF-000031517
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr).

Other devices from Drucker Diagnostics

See all devices from Drucker Diagnostics →

Properties

  • Professional testing
  • IVD instrument
  • Convenience kit
  • Combination product
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (18, all answered No)