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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-11 · Link to EUDAMED

STANDARD™ Q HCV Ab Test

UDI-DI 08800111723919Basic UDI-DI 88001117IPDA01QA07Z3

Class D · IVDR · SD Biosensor Inc.

Identification
Model
QHCV01B
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

V76 075369 0073

EU technical documentation assessment · unknown

Notified body: TÜV SÜD Product Service GmbH (0123)

Valid from 2026-09-29 · Expiry 2031-02-02

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

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/standardtm-q-hcv-ab-test-3919 · UDI page: /udi/08800111723919

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