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BFT II Analyzer 10458677

by Siemens Healthcare Diagnostics Products Ltd

Ref 10458677Model IVDR_27_MAR EB_A_INST_BFT_II

BFT II Analyzer 10458677 (OVKF032) 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 10 Jul 2026 (Basic UDI-DI 0405686900855W4), cleared under FDA 510(k) K984501 on 28 Jul 1999 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00842768024887), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K984501

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686900855W4 Basic UDI-DI 00842768024887UDI-DIDate10 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842768024887 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK984501 Date28 Jul 1999DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0405686900855W4 registered 10 Jul 2026 Active
  • FDA 510(k) K984501 decided 28 Jul 1999 Active
  • FDA GUDID UDI-DI 00842768024887 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K984501
  2. Listed FDA GUDID 00842768024887
  3. Registered EUDAMED 0405686900855W4

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  • Withdrawn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
BFT II Analyzer
Generic name
Coagulation analyser IVD, laboratory
Device name
IVDR_27_MAR Eb_a_inst_bft_II
Model / Ref / Catalog
10458677, IVDR_27_MAR EB_A_INST_BFT_II, OVKF032
Primary DI / UDI-DI
00842768024887
Basic UDI-DI
0405686900855W4
510(k) Number
FDA product code
JPA
EMDN code
W0202020101 Semi-automated coagulometers
GMDN term
Coagulation analyser IVD, laboratory
Device class
Class A EUDAMED
Class II GUDID
Regulation number
864.5425
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: Coagulation analyser IVD, laboratory, semi-automated

Cleared under the same submission (K984501)

Similar devices in this category

Other devices filed under SEMI-AUTOMATED COAGULOMETERS.

Other devices from Siemens Healthcare Diagnostics Products Ltd

See all devices from Siemens Healthcare Diagnostics Products Ltd →

Properties

  • Professional testing
  • IVD instrument
  • Serial number
Other properties (23, all answered No)