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UDI Compass
Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

AccuPower® HBV Quant Kit (ExiStation™ FA 96)

UDI-DI 08800242990068Basic UDI-DI 880953707HBV3116NB

Class D · IVDR · BIONEER Corporation

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

IVDR 818270

EU technical documentation assessment · valid

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

Valid from 2026-07-14 · Expiry 2031-07-13

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-hbv-quant-kit-existationtm-fa-96-0068 · UDI page: /udi/08800242990068

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