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Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

Saliva Pregnancy Test Kit

UDI-DI 06974541565745Basic UDI-DI 697454156019LE

Class B · IVDR · BioTeke Corporation（Wuxi）Co., Ltd

Identification
Model
1 Test/Kit,2 Tests/kit,5 Tests/kit,20 Tests/
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

EU-TDA-FI-43117-800031-2025

EU technical documentation assessment · valid

Notified body: Kiwa Sertio Oy (3018)

Valid from 2026-07-09 · Expiry 2030-05-30

Scope not stated in certificate data.

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

Manufacturer

BioTeke Corporation（Wuxi）Co., Ltd

SRN CN-MF-000007517

CN · Wuxi

manufacturer

Authorised representative: Medunion S.L. (ES-AR-000019366)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/saliva-pregnancy-test-kit-5745 · UDI page: /udi/06974541565745

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