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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-13 · Link to EUDAMED

Aptima HBV Quant Assay Target Enhancer Reagent

UDI-DI 15420045509108Basic UDI-DI 54200455DIAGAPTHBVAF

Class D · IVDR · Hologic

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

IVDR 779050

EU technical documentation assessment · unknown

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

Valid from 2025-11-17 · Expiry 2030-09-08

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-hbv-quant-assay-target-enhancer-reagent-9108 · UDI page: /udi/15420045509108

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