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Kaolin Suspension 10446033

by Siemens Healthcare Diagnostics Products Ltd

Ref 10446033Model IVDR_27_MAR EB_A_REAG_Kaolin

Kaolin Suspension 10446033 (OQAB45) is a device classified as Class A in the EU and Class II in the US made by Siemens Healthcare Diagnostics Products Ltd, registered in EUDAMED on 15 Jun 2026 (Basic UDI-DI 0405686900874W8), cleared under FDA 510(k) K925988 on 1 Mar 1993 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00842768007170), active as of 22 Oct 2026.

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

CE IVDR 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) K925988

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/IVDR EUDAMED Number0405686900874W8 Basic UDI-DI 00842768007170UDI-DIDate15 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842768007170 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK925988 Date1 Mar 1993DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0405686900874W8 registered 15 Jun 2026 Active
  • FDA 510(k) K925988 decided 1 Mar 1993 Active
  • FDA GUDID UDI-DI 00842768007170 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K925988
  2. Listed FDA GUDID 00842768007170
  3. Registered EUDAMED 0405686900874W8

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Kaolin Suspension
Generic name
Fibrinogen assay (factor I) IVD, reagent
Device name
IVDR_27_MAR EB_A_REAG_Kaolin
Model / Ref / Catalog
10446033, IVDR_27_MAR EB_A_REAG_Kaolin, OQAB45
Primary DI / UDI-DI
00842768007170
Basic UDI-DI
0405686900874W8
510(k) Number
FDA product code
KQJ
EMDN code
W0103020999 Auxiliary reagents (haemostasis) - other
GMDN term
Fibrinogen assay (factor I) IVD, reagent
Device class
Class A EUDAMED
Class II GUDID
Regulation number
864.7340
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 A
GUDID
Class II

Device class is stated on each registry's own scale: Class A 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: Fibrinogen assay (factor I) IVD, reagent

Cleared under the same submission (K925988)

Similar devices in this category

Other devices filed under AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER.

Other devices from Siemens Healthcare Diagnostics Products Ltd

See all devices from Siemens Healthcare Diagnostics Products Ltd →

Properties

  • Reagent
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)