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Snapshot 2026-10-13 · Link to EUDAMED

STANDARD™ Q COVID-19 Ag Test 2.0

UDI-DI 08800111715761Basic UDI-DI 88001117IPBA02QA04Y2

Class B · IVDR · SD Biosensor Inc.

Identification
Model
Q-NCOV-07G
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

V74 075369 0070

EU technical documentation assessment · restricted

Notified body: TÜV SÜD Product Service GmbH (0123)

Valid from 2025-11-14 · Expiry 2030-04-07

Scope not stated in certificate data.

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

Manufacturer

SD Biosensor Inc.

SRN KR-MF-000009168

KR · Gyeonggi-do, Suwon-si

manufacturer

Authorised representative: Medical Technology Promedt Consulting GmbH (DE-AR-000000085)

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/standardtm-q-covid-19-ag-test-2-0-5761 · UDI page: /udi/08800111715761

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