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Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

Aptima HCV Quant Dx Assay

UDI-DI 15420045509047Basic UDI-DI 54200455DIAGAPTHCVAJ

Class D · IVDR · Hologic

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

IVDR 779051

EU technical documentation assessment · valid

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-05-19 · Expiry 2031-05-18

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Hologic

SRN US-MF-000001646

US · San Diego

manufacturer

Authorised representative: Hologic BV (BE-AR-000000127)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/aptima-hcv-quant-dx-assay-9047 · UDI page: /udi/15420045509047

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