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Snapshot 2026-10-12 · Link to EUDAMED

Legacy device

Mycobacterium Tuberculosis Isoniazid and Fluoroquinolone Resistance Gene Test Kit (Fluorescent PCR Method)

UDI-DI 06974795550245Basic UDI-DI B-06974795550245

Unknown class · IVDD (legacy) · RocGene (Xuzhou) Technology Limited

Identification
Model
50 tests/kit
Issuing agency
GS1
Device status
active
Sterile
No
Manufacturer

RocGene (Xuzhou) Technology Limited

SRN CN-MF-000024511

CN · Xuzhou High-tech Industrial, Development Zone, 221100 Xuzhou, PEOPLE’S REPUBLIC OF CHINA

manufacturer

Authorised representative: Medunion S.L. (ES-AR-000019366)

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/mycobacterium-tuberculosis-isoniazid-and-fluoroquinolone-res-0245 · UDI page: /udi/06974795550245

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