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Enzygnost® F1+2 monoclonal 10445978

by Siemens Healthcare Diagnostics Products Ltd

Ref 10445978Model IVDR_27_MAR EB_C_KIT_Enz_F1+2_mono

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686900930VR Basic UDI-DI 00842768006760UDI-DIDate15 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842768006760 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Enzygnost F1+2 monoclonal EUDAMED
Enzygnost® F1+2 monoclonal GUDID
Generic Name
Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA)
Device Name
IVDR_27_MAR EB_C_KIT_Enz_F1+2_mono
Model / Ref / Catalog
10445978, IVDR_27_MAR EB_C_KIT_Enz_F1+2_mono, OPBD03
Primary DI / UDI-DI
00842768006760
Basic UDI-DI
0405686900930VR
510(k) Number
FDA Product Code
MIF
EMDN Code
W0103020306 Prothrombin fragment 1 + 2
GMDN Term
Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA)
Device Class
Class C EUDAMED
Class II GUDID
Regulation Number
864.7320
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

Related devices

Category: Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA)

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Properties

  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Professional Testing
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No