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EIAgen HBsAg Kit

by Adaltis SRL Italy EUDAMED

Ref 071011 / 071012 / 071015 EMDN W0105020201

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-++M521071045 Basic UDI-DIDate14 Jul 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  • Withdrawn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 · synced 24 Oct 2026

Model / Reference
071011 / 071012 / 071015
Primary DI / UDI-DI
++M521071045
Basic UDI-DI
B-++M521071045
EMDN Code
W0105020201 Hepatitis b surface antigen
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 049b1912-2392-4fab-9e7f-71f35cd91f71 61 fields · synced 24 Oct 2026