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Aptima HBV Quant Assay

by Hologic United States EUDAMED

Ref PRD-03424

EMDN W0105020216

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number54200455DIAGAPTHBVAF Basic UDI-DIDate29 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 779050 Amended

    Technical documentation EU IVDR

    Notified body
    Notified body 2797
    Issued
    17 Nov 2025
    Expires
    8 Sep 2030
    Reason
    Other

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
PRD-03424
Primary DI / UDI-DI
15420045509078
Basic UDI-DI
54200455DIAGAPTHBVAF
Direct Marketing DI
15420045509078
EMDN Code
W0105020216 Hepatitis b virus - na reagents
Device Class
Class D
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000001646
Authorised representative
Hologic BV BE-AR-000000127

Other devices from Hologic

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Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 15420045509078|54200455DIAGAPTHBVAF 61 fields · synced 25 Oct 2026