Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

HCG Pregnancy Rapid Tests for self-testing

UDI-DI 06970640090140Basic UDI-DI 697064009YF101EV

Class B · IVDR · Innovita (Tangshan) Biological Technology Co., Ltd.

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Identification

Model: Strip:YF101S001,YF101S002,YF101S003; Cassette: YF102C004, YF102C005, YF102C006; Midstream:YF103M007.YF103M008.YF103M009
EMDN: W0102160302
Issuing agency: GS1
Device status: active
Sterile: No

Certificates

IX 2006076-1

EU technical documentation assessment · valid

Notified body: TÜV Rheinland LGA Products GmbH (0197)

Valid from 2025-03-12 · Expiry 2030-03-11

Scope not stated in certificate data.

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

Manufacturer

Innovita (Tangshan) Biological Technology Co., Ltd.

SRN CN-MF-000018424

CN · Qian'an, Hebei,

manufacturer

Authorised representative: SUNGO Europe B.V. (NL-AR-000000247)

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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/hcg-pregnancy-rapid-tests-for-self-testing-0140 · UDI page: /udi/06970640090140

All devices from Innovita (Tangshan) Biological Technology Co., Ltd.

Scan an inventory CSV