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Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

China·CN-MF-000012807

Last updated September 17, 2026

Information

Country
China
Address
No. 888, Zhujiang Road, Juegang Street, Rudong County (Life & Health of Rudong High-tech Zone) , Nantong City, Jiangsu, China
LinkedIn
—
Facebook
—
Phone
—
PRRC Contact
Pengzhi Wang
EUDAMED SRN
CN-MF-000012807
FDA FEI Number
3016733849
DUNS Number
—

Catalogue (145)

Page 2 of 3
DeviceModel / ReferenceRegistriesClassStatus
Myo Test Kit (Fluorescence Immunoassay) HWTS-OT103
EUDAMED
IVD GeneralActive
Monkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography) HWTS-OT147C
EUDAMED
IVD GeneralActive
SARS-CoV-2 Variant B.1.617.2 Rapid Identification Kit (Fluorescence PCR) HWTS-RT091A
EUDAMED
IVD GeneralActive
AFP Test Kit (Fluorescence Immunoassay) HWTS-OT111
EUDAMED
IVD GeneralActive
SARS-COV-2, Influenza A and Influenza B Antigen Detection Kit (Immunochromatography) HWTS-RT096A
EUDAMED
IVD GeneralActive
Macro & Micro-Test Fluorescence Immunoassay Analyzer HWTS-EQ003
EUDAMED
Class AActive
Macro & Micro-Test Sample Release Reagent HWTS-3005-8A
EUDAMED
Class AActive
PRL Test Kit (Fluorescence Immunoassay) HWTS-OT107
EUDAMED
IVD GeneralActive
Freeze-dried Mycobacterium Tuberculosis Nucleic Acid and Rifampicin, Isoniazid Resistance Detection Kit (Melting Curve) HWTS-RT105
EUDAMED
IVD GeneralActive
Enterovirus Universal, EV71 and CoxA16 Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-EV026
EUDAMED
IVD GeneralActive
15 Types of High-risk Human Papillomavirus E6/E7 Gene mRNA Detection Kit (Fluorescence PCR) HWTS-CC005
EUDAMED
IVD GeneralActive
Macro & Micro-Test Viral DNA/RNA Column HWTS-3020-50
EUDAMED
Class AActive
NT-proBNP Test Kit (Fluorescence Immunoassay) HWTS-OT105
EUDAMED
IVD GeneralActive
Monkeypox Virus Typing Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-OT201
EUDAMED
IVD GeneralActive
Mycobacterium Tuberculosis Nucleic Acid and Rifampicin, Isoniazid Resistance Detection Kit (Melting Curve) HWTS-RT147
EUDAMED
IVD GeneralActive
CRP/SAA Combined Test Kit(Fluorescence Immunoassay) HWTS-OT120
EUDAMED
IVD GeneralActive
SARS-CoV-2, Respiratory Syncytium, and Influenza A&B Antigen Combined Detection Kit(Latex Method) HWTS-RT152
EUDAMED
IVD GeneralActive
SARS-CoV-2/influenza A /influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR) HWTS-RT060A
EUDAMED
IVD GeneralActive
FSH Test Kit (Fluorescence Immunoassay) HWTS-PF011
EUDAMED
IVD GeneralActive
SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva HWTS-RT062Y
EUDAMED
IVD GeneralActive
OXA23 Carbapenemase Detection Kit (Colloidal Gold) HWTS-OT118
EUDAMED
IVD GeneralActive
Macro & Micro-Test Automatic Nucleic Acid Extractor HWTS-3006
EUDAMED
Class AActive
Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens HWTS-RT058D
EUDAMED
IVD GeneralActive
Human Papillomavirus (28 Types) Genotyping Detection Kit (Fluorescence PCR) HWTS-CC007
EUDAMED
IVD GeneralActive
Macro & Micro-Test Viral DNA/RNA Kit HWTS-3017-50
EUDAMED
Class AActive
Monkeypox Virus Antigen Detection Kit (Immunochromatography) HWTS-OT079G
EUDAMED
IVD GeneralActive
Macro & Micro-Test Viral DNA/RNA Kit HWTS-3017-32
EUDAMED
Class AActive
Human TEL-AML1 Fusion Gene Mutation Detection Kit (Fluorescence PCR) HWTS-TM016
EUDAMED
IVD GeneralActive
SARS-CoV-2 IgG Antibody Detection Kit (Colloidal gold method) HWTS-RT094A
EUDAMED
IVD GeneralActive
TT4 Test Kit (Fluorescence Immunoassay) HWTS-OT094
EUDAMED
IVD GeneralActive
Bacillus Anthracis Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-OT018
EUDAMED
IVD GeneralActive
Macro & Micro-Test Sample Collecting, Mailing & Shipping Kit HWTS-3008-2
EUDAMED
Class AActive
14 Kinds of Respiratory Pathogens Combined Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-RT159
EUDAMED
IVD GeneralActive
SARS-COV-2 and Influenza A/B Antigen Detection Kit (Immunochromatography) HWTS-RT096B
EUDAMED
IVD GeneralActive
SARS-COV-2 and Influenza A/B Antigen Detection Kit (Immunochromatography) HWTS-RT096A
EUDAMED
IVD GeneralActive
Mycobacterium Tuberculosis Nucleic Acid and Rifampicin Resistance Detection Kit (Melting Curve) HWTS-RT074
EUDAMED
IVD GeneralActive
14 Types of High-risk Human Papillomavirus (16/18 Typing) Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-CC007
EUDAMED
IVD GeneralActive
Enzyme-Linked Immunosorbent Assay for detecting SARS-CoV-2 Neutralization Antibody HWTS-RT070A
EUDAMED
IVD GeneralActive
Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 HWTS-RT057A
EUDAMED
IVD GeneralActive
Macro & Micro-Test Bacterial DNA/RNA Kit HWTS-3011-32
EUDAMED
Class AActive
Macro & Micro-Test Viral DNA/RNA Kit HWTS-3017-96
EUDAMED
Class AActive
IL-6 Test Kit (Fluorescence Immunoassay) HWTS-OT099
EUDAMED
IVD GeneralActive
TT3 Test Kit (Fluorescence Immunoassay) HWTS-OT093
EUDAMED
IVD GeneralActive
SARS-CoV-2 Virus Antigen Detection Kit (Immunofluorescence Chromatography) HWTS-RT054A
EUDAMED
IVD GeneralActive
SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva HWTS-RT062F
EUDAMED
IVD GeneralActive
Human BCR-ABL Fusion Gene Mutation Detection Kit (Fluorescence PCR) HWTS-GE010
EUDAMED
IVD GeneralActive
PCT Test Kit (Fluorescence Immunoassay) HWTS-OT098
EUDAMED
IVD GeneralActive
PGI/PGII Combined Test Kit (Fluorescence Immunoassay) HWTS-OT116
EUDAMED
IVD GeneralActive
Macro & Micro-Test Viral DNA/RNA Kit HWTS-3017-962
EUDAMED
Class AActive
Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR) HWTS-RT105A
EUDAMED
IVD GeneralActive

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. US