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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 1 of 3
DeviceModel / ReferenceRegistriesClassStatus
Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-RT176A
EUDAMED
Class BActive
Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-RT176D
EUDAMED
Class BActive
Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-RT176C
EUDAMED
Class BActive
Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-RT176B
EUDAMED
Class BActive
Carbapenem Resistance Gene Detection Kit (Fluorescence PCR) HWTS-OT149C
EUDAMED
Class BActive
Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-RT176E
EUDAMED
Class BActive
Macro & Micro-Test General RNA Column HWTS-3024-50
EUDAMED
Class AActive
Carbapenem Resistance Gene Detection Kit(Fluorescence PCR) HWTS-OT045
EUDAMED
IVD GeneralActive
HGH Test Kit (Fluorescence Immunoassay) HWTS-OT115
EUDAMED
IVD GeneralActive
Macro & Micro-Test General DNA/RNA Kit HWTS-3019-48
EUDAMED
Class AActive
Fecal Occult Blood Test Kit (Colloidal Gold) HWTS-OT143
EUDAMED
IVD GeneralActive
Macro & Micro-Test Sample Release Reagent HWTS-3005-8D
EUDAMED
Class AActive
Macro & Micro-Test Sample Release Reagent HWTS-3005-8B
EUDAMED
Class AActive
Vitamin B12 Test Kit (Fluorescence Immunoassay) HWTS-OT109
EUDAMED
IVD GeneralActive
25-OH VD Test Kit (Fluorescence Immunoassay) HWTS-OT100
EUDAMED
IVD GeneralActive
Progesterone Test Kit(Fluorescence Immunoassay) HWTS-PF012
EUDAMED
IVD GeneralActive
SARS-CoV-2 (ORF1ab, N and 211-212del) Detection Kit (Fluorescence PCR) HWTS-RT104A
EUDAMED
IVD GeneralActive
CEA Test Kit (Fluorescence Immunoassay) HWTS-OT110
EUDAMED
IVD GeneralActive
18 Types of High-risk Human Papilloma Virus (16/18 Typing) Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-CC018
EUDAMED
IVD GeneralActive
Macro & Micro-Test Sample Collecting, Mailing & Shipping Kit HWTS-3008-5
EUDAMED
Class AActive
SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal gold method) HWTS-RT077A
EUDAMED
IVD GeneralActive
CK-MB Test Kit (Fluorescence Immunoassay) HWTS-OT104
EUDAMED
IVD GeneralActive
Fer Test Kit (Fluorescence Immunoassay) HWTS-OT106
EUDAMED
IVD GeneralActive
Macro & Micro-Test HCG Pregnancy Test Midstream K230741
FDA 510(k)
Class IIActive
Macro & Micro-Test Fluorescence Reader HWTS-EQ005
EUDAMED
Class AActive
Full Range C-Reactive Protein Test Kit (Fluorescence Immunoassay) HWTS-OT097
EUDAMED
IVD GeneralActive
EudemonTM AIO800 HWTS-EQ007
EUDAMED
Class AActive
SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method) HWTS-RT062C
EUDAMED
IVD GeneralActive
Dengue NS1 Antigen, IgM/IgG Antibody Dual Detection Kit (Immunochromatography) HWTS-FE031A
EUDAMED
IVD GeneralActive
Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Plasmodium HWTS-OT033A
EUDAMED
IVD GeneralActive
SAA Test Kit (Fluorescence Immunoassay) HWTS-OT112
EUDAMED
IVD GeneralActive
Freeze-dried 14 Types of Human Papillomavirus Nucleic Acid Typing Detection Kit (Fluorescence PCR) HWTS-CC021
EUDAMED
IVD GeneralActive
Macro & Micro-Test Viral DNA/RNA Kit HWTS-3017-482
EUDAMED
Class AActive
Human CYP2C9 and VKORC1 Gene Polymorphism Detection Kit (Fluorescence PCR) HWTS-GE014A
EUDAMED
IVD GeneralActive
Enzyme-Linked Immunosorbent Assay for detecting SARS-CoV-2 Spike RBD Antibody HWTS-RT055A
EUDAMED
IVD GeneralActive
Nucleic Acid Detection Kit for Clostridium difficile toxin A/B gene HWTS-OT031A
EUDAMED
IVD GeneralActive
Freeze-dried SARS-CoV-2/Influenza A/Influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR)-Subpackage HWTS-RT060E
EUDAMED
IVD GeneralActive
SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal gold method) HWTS-RT077B
EUDAMED
IVD GeneralActive
PCT/IL-6 Combined Test Kit (Fluorescence Immunoassay) HWTS-OT122
EUDAMED
IVD GeneralActive
Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold) HWTS-EV016A
EUDAMED
IVD GeneralActive
Freeze-dried Mycobacterium Tuberculosis Complex Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification) HWTS-RT144
EUDAMED
IVD GeneralActive
14 High-Risk HPV with 16/18 Genotyping Test Kit(Fluorescence PCR) HWTS-CC007A
EUDAMED
IVD GeneralActive
28 Types of Human Papillomavirus (16/18 Typing) Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-CC006
EUDAMED
IVD GeneralActive
Helicobacter Pylori and Toxin Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-OT139
EUDAMED
IVD GeneralActive
SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method) HWTS-RT062A
EUDAMED
IVD GeneralActive
Rapid identification Kit for B.1.1.7/B.1.351 and P.1 of SARS-CoV-2 (ARMS-PCR) HWTS-RT078A
EUDAMED
IVD GeneralActive
D-Dimer Test Kit (Fluorescence Immunoassay) HWTS-OT101
EUDAMED
IVD GeneralActive
Macro & Micro-Test General DNA/RNA Kit HWTS-3019-96
EUDAMED
Class AActive
LH Test Kit (Fluorescence Immunoassay) HWTS-PF010
EUDAMED
IVD GeneralActive
Sputasol HWTS-3012D
EUDAMED
Class AActive

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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