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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)

UDI-DI 06950996002844Basic UDI-DI 69509960GCFCRA-T525aDR65

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

Identification
Model
GCFCRA-T525a-DR
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

6188440CE01

EU quality management system · unknown

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

Valid from 2026-07-01 · Expiry 2030-04-01

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

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/covid-19-flu-a-b-rsv-adeno-ag-combo-rapid-test-cassette-swab-2844 · UDI page: /udi/06950996002844

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