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Certificate valid

Snapshot 2026-10-22 · Link to EUDAMED

EZER™ Flu & COVID-19 Antigen Duo Rapid Test

UDI-DI 16972698600811Basic UDI-DI 697269860RDT001SY

Class C · IVDR · Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.

Identification
Model
P213106, P213107, P213109
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

102/IVDR

EU technical documentation assessment · valid

Notified body: IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. (0051)

Valid from 2026-10-01 · Expiry 2031-09-30

Scope not stated in certificate data.

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

Manufacturer

Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.

SRN CN-MF-000013495

CN · Hangzhou

manufacturer

Authorised representative: Lotus NL B.V. (NL-AR-000000121)

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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/ezer-flu-covid-19-antigen-duo-rapid-test-0811 · UDI page: /udi/16972698600811

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