Adaltis_IVDD 22 012 0146

Certificate verification page

Certification scheme

Directive 98/79/EC on In Vitro Diagnostic Medical Devices
Annex IV Full quality assurance system and EC design examination

Certificate number

IVDD 22 012 0146
IVDD 22 012 0147

Certificate history

IVDD 22 012 0146 (Initial issue | 25.May.2022)
IVDD 22 012 0147 (Initial issue | 25.May.2022)

Manufacturer/Holder of certificate

Adaltis S.r.l.
Via Durini 27, 20122 Milano, Italy

Other sites

Via Luigi Einaudi 7, 00012 Guidonia Montecelio (RM), Italy

Effective from


Valid until


Suspension period
Withdrawn on
Validity status


Validity conditions

Products within scope

EIAgen HBsAg Kit


EIAgen HBsAg Kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative detection of HBsAg in human serum or plasma. It is intended for screening of blood donors and for diagnosing of patients related to infection with hepatitis B virus.


071011 (96 tests)
071012 (132 tests)
071015 (480 tests)


Device in List A