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RocGene (Xuzhou) Technology Limited

China·CN-MF-000024511

Last updated June 8, 2026

Information

Country
China
Address
Second Floor, Phase 1, Building 6, and Third Floor, Fourth Floor, Phase 1, Building 2, No. 10 Zhujiang East Road, Third Industrial Park, Xuzhou High-tech Industrial, Development Zone, 221100 Xuzhou, PEOPLE’S REPUBLIC OF CHINA, China
Website
rocgene.com
LinkedIn
—
Facebook
—
Phone
—
PRRC Contact
Yanfeng Cui
EUDAMED SRN
CN-MF-000024511
FDA FEI Number
—
DUNS Number
—

Catalogue (42)

DeviceModel / ReferenceRegistriesClassStatus
Real-Time PCR System Archimed Mini 16
EUDAMED
Class AActive
Dengue virus & Zika virus & Chikungunya virus & Hantavirus Nucleic Acid Test Kit (PCR-Fluorescent Probe Method) 10200162B
EUDAMED
IVD GeneralActive
Multiple Invasive Fungal Nucleic Acid Test Kit (Fluorescent PCR Method) 10210105A
EUDAMED
IVD GeneralActive
Six Carbapenem-resistant Gene Nucleic Acid Test Kit (PCR-Fluorescent Probe Method) 10210108A
EUDAMED
IVD GeneralActive
Five Infectious Diarrhea Virus Nucleic Acid Test Kit (PCR-Fluorescent Probe Method) 10200145A
EUDAMED
IVD GeneralActive
Nipah Virus Nucleic Acid Test Kit (PCR-Fluorescent Probe Method) 10201125A
EUDAMED
IVD GeneralActive
Dengue virus & Zika virus & Chikungunya virus & Hantavirus Nucleic Acid Test Kit (PCR-Fluorescent Probe Method) 10200162A
EUDAMED
IVD GeneralActive
Five Candida Nucleic Acid Test Kit (Fluorescent PCR Method) 10210004B
EUDAMED
IVD GeneralActive
Mycobacterium Tuberculosis Isoniazid and Fluoroquinolone Resistance Gene Test Kit (Fluorescent PCR Method) 10210102A
EUDAMED
IVD GeneralActive
Clostridium Difficile Toxin Gene Nucleic Acid Test Kit (PCR-Fluorescent Probe Method) 10210110A
EUDAMED
IVD GeneralActive
Coxsackievirus A6/A10/A16 & Enterovirus 71 & Enterovirus Universal Nucleic Acid Test Kit (PCR-Fluorescent Probe Method) 10200164B
EUDAMED
IVD GeneralActive
Mycobacteriaceae Identification Test Kit (PCR-Fluorescent Probe Method) 10210103B
EUDAMED
IVD GeneralActive
ESKAPE Multipathogenic Nucleic Acid Test Kit (Fluorescent PCR Method) 10210106A
EUDAMED
IVD GeneralActive
Five Food Borne Bacteria Nucleic Acid Test kit (PCR-Fluorescent Probe Method) 10200160B
EUDAMED
IVD GeneralActive
Five Respiratory Virus Nucleic Acid Test Kit (PCR Fluorescent Probe Method) 10210122A
EUDAMED
IVD GeneralActive
Clostridium Difficile Toxin Gene Nucleic Acid Test Kit (PCR-Fluorescent Probe Method) 10210110B
EUDAMED
IVD GeneralActive
ArchiPure Magnetic Viral DNA/RNA Extraction Kit (Prefilled) N/A
EUDAMED
Class AActive
Nipah Virus Nucleic Acid Test Kit (PCR-Fluorescent Probe Method) 10201125B
EUDAMED
IVD GeneralActive
Five Respiratory Pathogens Nucleic Acid Test Kit(PCR-Fluorescent Probe Method) 10210120B
EUDAMED
IVD GeneralActive
ESKAPE Multipathogenic Nucleic Acid Test Kit (Fluorescent PCR Method) 10210106B
EUDAMED
IVD GeneralActive
Five Candida Nucleic Acid Test Kit (Fluorescent PCR Method) 10210004A
EUDAMED
IVD GeneralActive
Six Carbapenem-resistant Gene Nucleic Acid Test Kit (PCR-Fluorescent Probe Method) 10210108B
EUDAMED
IVD GeneralActive
Real-Time PCR System Archimed Mini Pro
EUDAMED
Class AActive
Mycobacterium Tuberculosis Isoniazid and Fluoroquinolone Resistance Gene Test Kit (Fluorescent PCR Method) 10210102B
EUDAMED
IVD GeneralActive
Five Respiratory Pathogens Nucleic Acid Test Kit(PCR-Fluorescent Probe Method) 10210120A
EUDAMED
IVD GeneralActive
Carbapenem-resistant Gene Nucleic Acid Test Kit (Fluorescent PCR Method) 10210107B
EUDAMED
IVD GeneralActive
Mycobacterium Tuberculosis and Rifampicin Resistance Gene Test Kit (Fluorescent PCR Method) 10210001B
EUDAMED
IVD GeneralActive
Automatic Nucleic Acid Extractor ArchiPure 96 Pro
EUDAMED
Class AActive
Five Respiratory Virus Nucleic Acid Test Kit (PCR Fluorescent Probe Method) 10210122B
EUDAMED
IVD GeneralActive
Multiple Invasive Fungal Nucleic Acid Test Kit (Fluorescent PCR Method) 10210105B
EUDAMED
IVD GeneralActive
Staphylococcus Aureus and Methicillin-resistant Staphylococcus Aureus Nucleic Acid Test Kit (PCR-Fluorescent Probe Method) 10200163B
EUDAMED
IVD GeneralActive
Full-Automatic Nuceic Acid Detection and Analyzer iFIND S4
EUDAMED
Class AActive
Five Invasive Fungal Nucleic Acid Test Kit (Fluorescent PCR Method) 10210111A
EUDAMED
IVD GeneralActive
Five Food Borne Bacteria Nucleic Acid Test kit (PCR-Fluorescent Probe Method) 10200160A
EUDAMED
IVD GeneralActive
Mycobacterium Tuberculosis and Rifampicin Resistance Gene Test Kit (Fluorescent PCR Method) 10210001A
EUDAMED
IVD GeneralActive
SARS-CoV-2 Nucleic Acid Test Kit (PCR-Fluorescent Probe Method) 10210121A
EUDAMED
IVD GeneralActive
Dermatophyte Nucleic Acid Test Kit (Fluorescent PCR Method) 10210109A
EUDAMED
IVD GeneralActive
Full-Automatic Nuceic Acid Detection and Analyzer iFIND S8
EUDAMED
Class AActive
Diarrhea Related Pathogen Nucleic Acid Detection Kit(PCR-Fluorescent Probe Method) 10210113B
EUDAMED
IVD GeneralActive
Five Infectious Diarrhea Bacteria Nucleic Acid Test Kit (PCR-Fluorescent Probe Method) 10200159A
EUDAMED
IVD GeneralActive
Coxsackievirus A6/A10/A16 & Enterovirus 71 & Enterovirus Universal Nucleic Acid Test Kit (PCR-Fluorescent Probe Method) 10200164A
EUDAMED
IVD GeneralActive
Real-Time PCR System Archimed X4
EUDAMED
Class AActive

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