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UDI Compass
Certificate valid

Snapshot 2026-10-28 · Link to EUDAMED

AmniSure ROM Test

UDI-DI 14053228046391Basic UDI-DI 4053228RAS0000000000001MP

Class C · IVDR · QIAGEN Sciences LLC

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

IX 1545122-2

EU technical documentation assessment · valid

Notified body: TÜV Rheinland LGA Products GmbH (0197)

Valid from 2025-11-10 · Expiry 2030-11-09

Scope not stated in certificate data.

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

Manufacturer

QIAGEN Sciences LLC

SRN US-MF-000014502

US · Germantown

manufacturer

Authorised representative: QIAGEN GmbH (DE-AR-000004971)

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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/amnisure-rom-test-6391 · UDI page: /udi/14053228046391

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