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Cuvettes for BFT // Analyzer 10446541

by Siemens Healthcare Diagnostics Products Ltd

Ref 10446541Model IVDR_27_MAR EB_A_Cuv_BFT_II

Cuvettes for BFT // Analyzer 10446541 (OVMN11) 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 0405686902119VB), cleared under FDA 510(k) K984501 on 28 Jul 1999 and listed in FDA GUDID since 31 Oct 2017 (UDI-DI 00842768012358), 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, self-declared

Class I: no certifier involved

510(k) K984501

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 Number0405686902119VB Basic UDI-DI 00842768012358UDI-DIDate10 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842768012358 UDI-DI Date31 Oct 2017ListedStatusListed 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 0405686902119VB registered 10 Jul 2026 Active
  • FDA 510(k) K984501 decided 28 Jul 1999 Active
  • FDA GUDID UDI-DI 00842768012358 listed 31 Oct 2017 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K984501
  2. Listed FDA GUDID 00842768012358
  3. Registered EUDAMED 0405686902119VB

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  • Withdrawn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 EUDAMED
Cuvettes for BFT // Analyzer GUDID
Generic name
Laboratory analyser cuvette IVD, single-use
Device name
IVDR_27_MAR EB_A_Cuv_BFT_II
Model / Ref / Catalog
10446541, IVDR_27_MAR EB_A_Cuv_BFT_II, OVMN11
Primary DI / UDI-DI
00842768012358
Basic UDI-DI
0405686902119VB
Unit of use DI
00842768025006
510(k) Number
FDA product code
JPA
EMDN code
W0202020185 Coagulometers - consumables
GMDN term
Laboratory analyser cuvette IVD, single-use
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 COAGULOMETERS.

Other devices from Siemens Healthcare Diagnostics Products Ltd

See all devices from Siemens Healthcare Diagnostics Products Ltd →

Properties

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