Skip to content

NOVA Lite® DAPI ANA HEp-2 Pro

by Inova Diagnostics. Inc. United States EUDAMED

Ref 704325 EMDN W0102100101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0195126001250PH Basic UDI-DIDate8 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
704325
Primary DI / UDI-DI
00195126001250
Basic UDI-DI
0195126001250PH
EMDN Code
W0102100101 Ana screening
Device Class
Class B
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
US-MF-000017851
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Inova Diagnostics, Inc.

See all devices from Inova Diagnostics, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 00195126001250|0195126001250PH 61 fields · synced 24 Oct 2026