Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

LH Ovulation Rapid Test for self-testing

UDI-DI 06970640090171Basic UDI-DI 697064009YF104F3

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

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Identification

Model: Strip: YF104S010,YF104S011; Cassette: YF105C012,YF105C013; Midstream: YF106M014.YF106M015
EMDN: W0102160304
Issuing agency: GS1
Device status: active
Sterile: No

Certificates

IX 2006076-2

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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LH Ovulation Rapid Test for self-testing 06970640090294
LH Ovulation Rapid Test for self-testing 06970640090188
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LH Ovulation Rapid Test for self-testing 06970640090270
LH Ovulation Rapid Test for self-testing 06970640090287

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/lh-ovulation-rapid-test-for-self-testing-0171 · UDI page: /udi/06970640090171

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

Scan an inventory CSV