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INNOVANCE DTI Assay

by Siemens Healthcare Diagnostics Products GmbH 2 variants

Ref 10873467Model IVDR_27_MAR EB_C_KIT_INN_DTI

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686900933VX Basic UDI-DI 00842768014482UDI-DIDate15 Jun 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
IVDR_27_MAR Eb_c_kit_inn_dti
Model / Reference
IVDR_27_MAR EB_C_KIT_INN_DTI, 10873467
Primary DI / UDI-DI
00842768014482
Basic UDI-DI
0405686900933VX
EMDN Code
W0103020399 Special coagulation tests - other
Device Class
Class C
EU market of registration
Germany

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

  • Animal Tissues
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No