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Snapshot 2026-10-25 · Link to EUDAMED

cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA)

UDI-DI 06950996047043Basic UDI-DI 69509960FDCAR-T402a-DRQ4

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

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Identification

Model: FDCAR-T402a-DR10, FDCAR-T402a-DR10LH, FDCAR-T402a-DR10HG, FDCAR-T402a-DR, FDCAR-T402a-DRLH, FDCAR-T402a-DRHG
EMDN: W0102160706
Issuing agency: GS1
Device status: active
Sterile: No

Certificates

No certificate found.

Snapshot 2026-10-25 · Link to EUDAMED

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

cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA) 06950996061698
cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA) 06950996003872
cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA) 06950996037464
cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA) 06950996003865
cTnI/CK-MB/Myo Quantitative Test Kit(Time-Resolved FIA) 06950996038959

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/ctni-ck-mb-myo-quantitative-test-kit-time-resolved-fia-7043 · UDI page: /udi/06950996047043

All devices from Zhejiang Orient Gene Biotech Co., Ltd

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