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UDI Compass
Certificate valid

Snapshot 2026-10-28 · Link to EUDAMED

AccuPower® HIV-1 Quantitative RT-PCR Kit

UDI-DI 08809537070256Basic UDI-DI 880953707HIV1211QK

Class D · IVDR · BIONEER Corporation

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

IX 2134964-1

EU technical documentation assessment · valid

Notified body: TÜV Rheinland LGA Products GmbH (0197)

Valid from 2026-09-03 · Expiry 2031-09-02

Scope not stated in certificate data.

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

Manufacturer

BIONEER Corporation

SRN KR-MF-000018672

KR · Daejeon

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/accupower-hiv-1-quantitative-rt-pcr-kit-0256 · UDI page: /udi/08809537070256

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