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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 3 of 3
DeviceModel / ReferenceRegistriesClassStatus
TSH Test Kit (Fluorescence Immunoassay) HWTS-OT092
EUDAMED
IVD GeneralActive
Carbapenemase Detection Kit (Colloidal Gold) HWTS-OT085
EUDAMED
IVD GeneralActive
SARS-CoV-2 IgG Antibody Detection Kit (Colloidal gold method) HWTS-RT094B
EUDAMED
IVD GeneralActive
SARS-CoV-2, Influenza A&B Antigen Combined Detection Kit (Immunochromatography) HWTS-RT101B
EUDAMED
IVD GeneralActive
SARS-COV-2, Influenza A and Influenza B Antigen Detection Kit (Immunochromatography) HWTS-RT096B
EUDAMED
IVD GeneralActive
SARS-CoV-2, Flu A&B Antigen, RSV, ADV, and MP Combined Detection Kit (Latex Method) HWTS-RT170A
EUDAMED
IVD GeneralActive
Macro & Micro-Test Genomic DNA/RNA Kit HWTS-3010-96
EUDAMED
Class AActive
Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Dengue virus HWTS-FE024A
EUDAMED
IVD GeneralActive
Influenza A/B Antigen Detection Kit (Immunochromatography) HWTS-RT130
EUDAMED
IVD GeneralActive
G17 Test Kit (Fluorescence Immunoassay) HWTS-OT117
EUDAMED
IVD GeneralActive
Mycobacterium Tuberculosis Isoniazid Resistance Mutation Detection Kit(Melting Curve) HWTS-RT137
EUDAMED
IVD GeneralActive
SARS-CoV-2, Influenza A&B Antigen Combined Detection Kit (Immunochromatography) HWTS-RT101A
EUDAMED
IVD GeneralActive
Macro & Micro-Test Genomic DNA/RNA Kit HWTS-3010-32
EUDAMED
Class AActive
cTnI Test Kit (Fluorescence Immunoassay) HWTS-OT102
EUDAMED
IVD GeneralActive
Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for SARS-CoV-2 HWTS-RT095A
EUDAMED
IVD GeneralActive
Macro & Micro-Test Viral DNA/RNA Kit HWTS-3017-8
EUDAMED
Class AActive
Freeze-dried Human Papillomavirus (28 Types) Genotyping Detection Kit (Fluorescence PCR) HWTS-CC016
EUDAMED
IVD GeneralActive
Freeze-dried Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 HWTS-RT057G
EUDAMED
IVD GeneralActive
Monkeypox Virus and Typing Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-OT202
EUDAMED
IVD GeneralActive
17 Types of Human Papillomavirus (16/18/6/11/44 Typing) Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-CC015
EUDAMED
IVD GeneralActive
Dengue NS1 Antigen, IgM/IgG Antibody Dual Detection Kit (Immunochromatography) HWTS-FE031B
EUDAMED
IVD GeneralActive
Macro & Micro-Test General DNA/RNA Kit HWTS-3019-32
EUDAMED
Class AActive
Macro & Micro-Test Sample Release Reagent HWTS-3005-8C
EUDAMED
Class AActive
Macro & Micro-Test Fluorescence Immunoassay Analyzer HWTS-EQ006
EUDAMED
Class AActive
Macro & Micro-Test General DNA/RNA Column HWTS-3021-50
EUDAMED
Class AActive
Dengue Virus, Zika Virus and Chikungunya Virus Multiplex Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-FE040
EUDAMED
IVD GeneralActive
Monkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography) HWTS-OT145B
EUDAMED
IVD GeneralActive
Monkeypox Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification) HWTS-OT200B
EUDAMED
IVD GeneralActive
SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method) HWTS-RT062D
EUDAMED
IVD GeneralActive
Mycoplasma Pneumoniae Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-RT024
EUDAMED
IVD GeneralActive
Macro & Micro-Test Sample Collecting, Mailing & Shipping Kit HWTS-3008-1
EUDAMED
Class AActive
Freeze-dried SARS-CoV-2/Influenza A/Influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR) HWTS-RT060F
EUDAMED
IVD GeneralActive
Easy Amp Real-time Fluorescence Isothermal Detection System HWTS-EQ002
EUDAMED
Class AActive
14 Kinds of Genitourinary Tract Infection Pathogen Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-UR040
EUDAMED
IVD GeneralActive
Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens HWTS-RT058A
EUDAMED
IVD GeneralActive
Human Leukocyte Antigen B27 Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-GE011
EUDAMED
IVD GeneralActive
Monkeypox Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification) HWTS-OT200A
EUDAMED
IVD GeneralActive
HbA1c Test Kit (Fluorescence Immunoassay) HWTS-OT091
EUDAMED
IVD GeneralActive
Macro & Micro-Test Genomic DNA/RNA Kit HWTS-3010-48
EUDAMED
Class AActive
SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method) HWTS-RT062B
EUDAMED
IVD GeneralActive
β-HCG Test Kit (Fluorescence Immunoassay) HWTS-PF009
EUDAMED
IVD GeneralActive
SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva HWTS-RT062Z
EUDAMED
IVD GeneralActive
SARS-CoV-2 IgM/IgG Antibody Detection Kit (Colloidal gold method) HWTS-RT090A
EUDAMED
IVD GeneralActive
Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Group B Streptococcus HWTS-UR010A
EUDAMED
IVD GeneralActive
4 Kinds of Respiratory Viruses Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-RT099
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