Certificate valid

Snapshot 2026-10-22 · Link to EUDAMED

DIAGOTEC HCG Pregnancy Rapid Test

UDI-DI 06976838234617Basic UDI-DI 697683823P201600ES

Class B · IVDR · GenSure Biotech Inc.

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Identification

Model: P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50
EMDN: W0102160302
Issuing agency: GS1
Device status: active
Sterile: No

Certificates

V76 126886 0004

EU technical documentation assessment · valid

Notified body: TÜV SÜD Product Service GmbH (0123)

Valid from 2025-07-16 · Expiry 2030-07-15

Scope not stated in certificate data.

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

Manufacturer

GenSure Biotech Inc.

SRN CN-MF-000028354

CN · Shanghai

manufacturer

Authorised representative: RIOMAVIX SOCIEDAD LIMITADA (ES-AR-000001202)

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Canonical device page: /device/diagotec-hcg-pregnancy-rapid-test-4617 · UDI page: /udi/06976838234617

All devices from GenSure Biotech Inc.

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