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ENGENOME srl

Italy IT-MF-000029171 Last updated 21 Oct 2026

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Devices
2
Registries
EUDAMED
FDA recalls
0

Catalogue2

  • eVai Ref 80562097200122

    IVD General EUDAMED Active

  • eVai Ref eVai

    Class C EUDAMED Active

EUDAMED certificates2

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (2)

Notified body 0051 1 certificate

  • 101/IVDR Issued

    Quality management system EU IVDR

    Issued
    7 Aug 2026
    Expires
    25 Feb 2031

QMD Services GmbH 2962 1 certificate

  • IQMS/00007/0v001 Withdrawn

    Quality management system EU IVDR

    Issued
    26 Feb 2026
    Expires
    25 Feb 2031
    Reason
    Transferred to other nb

Related companies

Notified bodies

About

enGenome: AI-guided software for clinical genomic interpretation, helping laboratories prioritise, classify and report genomic variants with confidence.

From the manufacturer's own website. Source

Information

Country
Italy
Address
5, VIA A. FERRATA, Pavia, Italy
PRRC contact
Susanna Maria Zucca
EUDAMED SRN
IT-MF-000029171