Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

EuroGen LH Ovulation Rapid Test

UDI-DI 16976838235215Basic UDI-DI 697683823P201100DZ

Class B · IVDR · GenSure Biotech Inc.

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Identification

Model: P2011C03, P2011C05, P2011C25; P2011M02, P2011M03, P2011M05, P2011M07, P2011M25; P2011S10, P2011S25, P2011S50; Y2011C03, Y2011C05, Y2011C25; Y2011M02, Y2011M03, Y2011M05, Y2011M07, Y2011M25; Y2011S10, Y2011S25, Y2011S50
EMDN: W0102160304
Issuing agency: GS1
Device status: active
Sterile: No

Certificates

V76 126886 0003

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/eurogen-lh-ovulation-rapid-test-5215 · UDI page: /udi/16976838235215

All devices from GenSure Biotech Inc.

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