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Certificate valid

Snapshot 2026-10-28 · Link to EUDAMED

hCG Pregnancy Rapid Test Kit (Urine)

UDI-DI 06974042872168Basic UDI-DI 697404287216K8

Class B · IVDR · Hangzhou Frenovo Biotech Co.,Ltd.

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

IVDR 790654

EU technical documentation assessment · valid

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2025-02-06 · Expiry 2030-02-05

Scope not stated in certificate data.

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

Manufacturer

Hangzhou Frenovo Biotech Co.,Ltd.

SRN CN-MF-000008729

CN · Hangzhou

manufacturer

Authorised representative: CMC Medical Devices & Drugs SL (ES-AR-000000293)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/hcg-pregnancy-rapid-test-kit-urine-2168 · UDI page: /udi/06974042872168

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