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INNOVANCE D-Dimer 2.0 CONTROL 3

by Siemens Healthcare Diagnostics Products GmbH EUDAMEDGUDID

Active European Union

Ref 10874093Model IVDR_27_MAR EB_C_PROF_INN_D_Di_Con_2

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00630414656038 UDI-DIDate19 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number0405686902243VD Basic UDI-DIDate18 Jun 2026RegisteredStatusActive

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
D-dimer IVD, control
Device Name
IVDR_27_MAR EB_C_PROF_INN_D_Di_Con_2
Model / Ref / Catalog
IVDR_27_MAR EB_C_PROF_INN_D_Di_Con_2, 10874093
Primary DI / UDI-DI
00630414656038
Basic UDI-DI
0405686902243VD
Unit of Use DI
00630414324357
510(k) Number
FDA Product Code
DAP
EMDN Code
W0103020799 Haemostasis controls - other
GMDN Term
D-dimer IVD, control
Device Class
Class C EUDAMED
Class II GUDID
Regulation Number
864.7320
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

Manufacturer details

EUDAMED SRN
DE-MF-000005039

Other devices from Siemens Healthcare Diagnostics Products GmbH

See all devices from Siemens Healthcare Diagnostics Products GmbH →

Properties

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

Other properties (17)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: 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