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EIAgen Detect HIV Combo Kit

by Adaltis SRL EUDAMED

Active European Union

Ref 081311C / 081312C / 081315CModel ++M52108131C

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-++M52108131CB3 Basic UDI-DIDate6 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
++M52108131C, 081311C / 081312C / 081315C
Primary DI / UDI-DI
++M52108131CB3
Basic UDI-DI
B-++M52108131CB3
EMDN Code
W0105030404 HIV multiple ag/ab combi test
Device Class
Class IVD Annex II List A
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
IT-MF-000028990

Other devices from Adaltis SRL

See all devices from Adaltis SRL →

Properties

Show properties
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No