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Multifibren U 10873901

by Siemens Healthcare Diagnostics Products Ltd

Ref 10873901Model IVDR_27_MAR EB_C_REAG_Multifib_U

Multifibren U 10873901 is an in vitro diagnostic device (EU IVDR Class C; FDA Class II; FDA product code KQJ, System, Fibrinogen Determination) made by Siemens Healthcare Diagnostics Products Ltd, registered in EUDAMED on 15 Jun 2026 (Basic UDI-DI 0405686900877WE), cleared under FDA 510(k) K934326 on 19 Apr 1994 and listed in FDA GUDID since 25 Mar 2024 (UDI-DI 00630414639741), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K934326

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686900877WE Basic UDI-DI 00630414639741UDI-DIDate15 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414639741 UDI-DI Date25 Mar 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK934326 Date19 Apr 1994DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0405686900877WE registered 15 Jun 2026 Active
  • FDA 510(k) K934326 decided 19 Apr 1994 Active
  • FDA GUDID UDI-DI 00630414639741 listed 25 Mar 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K934326
  2. Listed FDA GUDID 00630414639741
  3. Registered EUDAMED 0405686900877WE

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  • Withdrawn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
Multifibren U
Generic name
Fibrinogen assay (factor I) IVD, reagent
Device name
IVDR_27_MAR EB_C_REAG_Multifib_U
Model / Ref / Catalog
10873901, IVDR_27_MAR EB_C_REAG_Multifib_U
Primary DI / UDI-DI
00630414639741
Basic UDI-DI
0405686900877WE
Unit of use DI
00842768018503
510(k) Number
FDA product code
KQJ
EMDN code
W0103020201 Fibrinogen assays (factor i)
GMDN term
Fibrinogen assay (factor I) IVD, reagent
Device class
Class C 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 C
GUDID
Class II

Device class is stated on each registry's own scale: Class C 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 (K934326)

Similar devices in this category

Other devices filed under FIBRINOGEN ASSAYS (FACTOR I).

Other devices from Siemens Healthcare Diagnostics Products Ltd

See all devices from Siemens Healthcare Diagnostics Products Ltd →

Properties

  • Contains animal tissues or cells
  • Reagent
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)