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UDI Compass
Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

COVID-19/RSV/Flu A+B Ag Rapid Test

UDI-DI 16976838230593Basic UDI-DI 697683823P208100FJ

Class C · IVDR · GenSure Biotech Inc.

Identification
Model
P2081C01, P2081C02, P2081C05, P2081C20.
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

6211186TD01

EU technical documentation assessment · valid

Notified body: DEKRA Certification B.V. (0344)

Valid from 2026-01-20 · Expiry 2031-01-01

Scope not stated in certificate data.

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

6211186CE01

EU quality management system · valid

Notified body: DEKRA Certification B.V. (0344)

Valid from 2026-01-20 · Expiry 2031-01-01

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/covid-19-rsv-flu-a-b-ag-rapid-test-0593 · UDI page: /udi/16976838230593

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