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Aptiva® Vasculitis - 3 Pack

by Inova Diagnostics. Inc. United States EUDAMED

Ref 722104

EMDN W0102100402,W0102100403

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0195126001069PU Basic UDI-DIDate26 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Aptiva® Vasculitis - 1 Pack
Model / Reference
722104
Primary DI / UDI-DI
00195126001076
Basic UDI-DI
0195126001069PU
EMDN Code
W0102100402,W0102100403
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
  • New Device
Other properties (6)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 00195126001076|0195126001069PU 61 fields · synced 24 Oct 2026