Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

DIAGOTEC Strep A Rapid Test

UDI-DI 06976838234907Basic UDI-DI 697683823P201900F9

Class C · IVDR · GenSure Biotech Inc.

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Identification

Model: —
EMDN: W0105090103
Issuing agency: GS1
Device status: active
Sterile: No

Certificates

V76 126886 0005

EU technical documentation assessment · valid

Notified body: TÜV SÜD Product Service GmbH (0123)

Valid from 2025-07-11 · Expiry 2030-07-10

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)

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Showing 12 of 13 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/diagotec-strep-a-rapid-test-4907 · UDI page: /udi/06976838234907

All devices from GenSure Biotech Inc.

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