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UDI Compass
Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

Rapid Flu A&B+RSV+Adeno Antigen Test

UDI-DI 06950996004084Basic UDI-DI 69509960GCFRA-T525aDRH3A

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

Identification
Model
GCFRA-T525a-DRH1/GCFRA-T525a-DRH5/GCFRA-T525a-DRH7/GCFRA-T525a-DRH20
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

V76 092305 0014

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-flu-a-b-rsv-adeno-antigen-test-4084 · UDI page: /udi/06950996004084

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