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UDI Compass
Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

Rapid Influenza A & B Antigen Test

UDI-DI 06950996002646Basic UDI-DI 69509960GCFLUAB502aDRHGQ

Class C · IVDR · Zhejiang Orient Gene Biotech Co., Ltd

Identification
Model
GCFLU(A/B)-502a-DRH1,GCFLU(A/B)-502a-DRH2,GCFLU(A/B)-502a-DRH5,GCFLU(A/B)-502a-DRH7,GCFLU(A/B)-502a-DRH20
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

V76 092305 0013

EU technical documentation assessment · valid

Notified body: TÜV SÜD Product Service GmbH (0123)

Valid from 2026-06-30 · Expiry 2030-04-17

Scope not stated in certificate data.

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

Manufacturer

Zhejiang Orient Gene Biotech Co., Ltd

SRN CN-MF-000017965

CN · Huzhou,Zhejiang

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/rapid-influenza-a-b-antigen-test-2646 · UDI page: /udi/06950996002646

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