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UDI Compass
Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

EuroGen Flu A+B Ag Rapid Test

UDI-DI 16976838235338Basic UDI-DI 697683823P201800F4

Class C · IVDR · GenSure Biotech Inc.

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

V76 126886 0006

EU technical documentation assessment · valid

Notified body: TÜV SÜD Product Service GmbH (0123)

Valid from 2025-07-14 · Expiry 2030-07-13

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)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/eurogen-flu-a-b-ag-rapid-test-5338 · UDI page: /udi/16976838235338

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