Fabricant

Jiangsu Macro & Micro-Test Med-Tech

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

Marchés : Allemagne · Espagne · États-Unis

Autorisations : UE – classe A, B, C · États-Unis (FDA) – 510(k) : 1 · classe I, II · dernière en 2023 · voir sur le site de la FDA

Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)

marketing@hongweitest.com

34 catégories, 98 modèles dont 98 en vente, 1 pays

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93/42 Ancienne directive, pas encore certifié selon le règlement MDR
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Catégorie	Code EMDN	Modèles enregistrés	Classe	Contact
Reagents for DNA and/or RNA amplification and/or detection: bacteria and/or virus	W0105900102	Freeze-dried Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 -Subpackage 48 tests/kit98/79 Freeze-dried Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 50 tests/kit98/79 Freeze-dried SARS-CoV-2/Influenza A/Influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR) 50 tests/kit98/79 Freeze-dried SARS-CoV-2/Influenza A/Influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR)-Subpackage 48 tests/kit98/79 Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Dengue virus98/79 12 autres Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Enterovirus98/79 Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Influenza A virus98/79 Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Novel Coronavirus (SARS-CoV-2) 16 tests/kit98/79 Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for SARS-CoV-2 16 tests/kit98/79 Rapid identification Kit for B.1.1.7/B.1.351 and P.1 of SARS-CoV-2 (ARMS-PCR) 50 tests/kit98/79 Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens 24 tests/kit98/79 Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens 25 tests/kit98/79 Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens 48 tests/kit98/79 Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens 50tests/kit98/79 Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 50 tests/kit98/79 SARS-CoV-2 Variant B.1.617.2 Rapid Identification Kit (Fluorescence PCR) 50 tests/kit98/79 SARS-CoV-2/influenza A /influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR) 50 tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Virology - RT & POC - other	W0105099099	SARS-CoV-2 IgG Antibody Detection Kit (Colloidal gold method) 1 test/kit98/79 SARS-CoV-2 IgG Antibody Detection Kit (Colloidal gold method) 20 tests/kit98/79 SARS-CoV-2 IgM/IgG Antibody Detection Kit (Colloidal gold method) 1 test/kit98/79 SARS-CoV-2 IgM/IgG Antibody Detection Kit (Colloidal gold method) 20 tests/kit98/79 SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal gold method) 1 test/kit98/79 11 autres SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal gold method) 20 tests/kit98/79 SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method) 1 test/kit (Nasal Swab)98/79 SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method) 1 test/kit (Nasopharyngeal swab)98/79 SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method) 1 test/kit (Rachenabstrichen)98/79 SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method) 1 test/kit (Speichel)98/79 SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method) 10 tests/kit (Speichel)98/79 SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method) 20 tests/kit (Speichel)98/79 SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva 1 test/kit98/79 SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva 10 tests/kit98/79 SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva 20 tests/kit98/79 SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva 5 tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Viral antigen/antibody detection - other	W0105040699	Monkeypox Virus Antigen Detection Kit (Immunochromatography) 1 test/kit98/79 Monkeypox Virus Antigen Detection Kit (Immunochromatography) 20 tests/kit98/79 Monkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography) 1 test/kit98/79 Monkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography) 20 tests/kit98/79 Monkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography) 5 tests/kit98/79 2 autres SARS-CoV-2, Flu A&B Antigen, RSV, ADV, and MP Combined Detection Kit (Latex Method) 1 test/kit98/79 SARS-CoV-2, Flu A&B Antigen, RSV, ADV, and MP Combined Detection Kit (Latex Method) 20 tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Multiple viruses - other	W01050799	SARS-COV-2 and Influenza A/B Antigen Detection Kit (Immunochromatography) 1 test/kit98/79 SARS-COV-2 and Influenza A/B Antigen Detection Kit (Immunochromatography) HWTS-RT096B98/79 SARS-COV-2, Influenza A and Influenza B Antigen Detection Kit (Immunochromatography) 1 test/kit98/79 SARS-COV-2, Influenza A and Influenza B Antigen Detection Kit (Immunochromatography) 20 tests/kit98/79 SARS-CoV-2, Influenza A&B Antigen Combined Detection Kit (Immunochromatography) 1 test/kit98/79 1 autre SARS-CoV-2, Influenza A&B Antigen Combined Detection Kit (Immunochromatography) 20 tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Partial genotyping high-risk HPV - NA reagents	W0105041003	14 Types of High-risk Human Papillomavirus (16/18 Typing) Nucleic Acid Detection Kit (Fluorescence PCR)98/79 17 Types of Human Papillomavirus (16/18/6/11/44 Typing) Nucleic Acid Detection Kit (Fluorescence PCR)98/79 18 Types of High-risk Human Papilloma Virus (16/18 Typing) Nucleic Acid Detection Kit (Fluorescence PCR)98/79 Freeze-dried 14 Types of Human Papillomavirus Nucleic Acid Typing Detection Kit (Fluorescence PCR)98/79 Freeze-dried Human Papillomavirus (28 Types) Genotyping Detection Kit (Fluorescence PCR)98/79 1 autre Human Papillomavirus (28 Types) Genotyping Detection Kit (Fluorescence PCR)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Virology - NA reagents - other	W0105040599	Monkeypox Virus and Typing Nucleic Acid Detection Kit (Fluorescence PCR)98/79 Monkeypox Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification) 16 tests/kit98/79 Monkeypox Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification) 20 tests/kit98/79 Monkeypox Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification) 48 tests/kit98/79 Monkeypox Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification) 50 tests/kit98/79 1 autre Monkeypox Virus Typing Nucleic Acid Detection Kit (Fluorescence PCR)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Mycobacterial detection by NA reagents	W0105010703	Freeze-dried Mycobacterium Tuberculosis Complex Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification)98/79 Freeze-dried Mycobacterium Tuberculosis Nucleic Acid and Rifampicin, Isoniazid Resistance Detection Kit (Melting Curve)98/79 Mycobacterium Tuberculosis Isoniazid Resistance Mutation Detection Kit(Melting Curve)98/79 Mycobacterium Tuberculosis Nucleic Acid and Rifampicin Resistance Detection Kit (Melting Curve)98/79 Mycobacterium Tuberculosis Nucleic Acid and Rifampicin, Isoniazid Resistance Detection Kit (Melting Curve)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Mycobacteria reagents - other	W0105010799	Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR) 20 tests/kit98/79 Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR) 48 tests/kit98/79 Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR) 50 tests/kit98/79 Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Mycobacterium tuberculosis 50 tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Respiratory tract infections - multiplex NA reagents	W0105070503	14 Kinds of Respiratory Pathogens Combined Nucleic Acid Detection Kit (Fluorescence PCR)98/79 4 Kinds of Respiratory Viruses Nucleic Acid Detection Kit (Fluorescence PCR)98/79 SARS-CoV-2, Respiratory Syncytium, and Influenza A&B Antigen Combined Detection Kit(Latex Method)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Dengue virus	W0105040611	Dengue NS1 Antigen, IgM/IgG Antibody Dual Detection Kit (Immunochromatography) 1 test/kit98/79 Dengue NS1 Antigen, IgM/IgG Antibody Dual Detection Kit (Immunochromatography) 20 tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Multiple viruses - multiplex assays - other	W0105070399	Dengue Virus, Zika Virus and Chikungunya Virus Multiplex Nucleic Acid Detection Kit (Fluorescence PCR)98/79 Influenza A/B Antigen Detection Kit (Immunochromatography)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Other multiple pathogens - RT & POC	W0105090699	COVID-19 /Flu A &B/ RSV/ADV Ag Combo Rapid Test HWTS-RT065A3 réf. RSV/ADV Ag Rapid Test HWTS-RT201A3 réf.	C IVDR	Fiche EUDAMED Signaler une erreur
Bacteriology - NA reagents - other	W0105011699	Bacillus Anthracis Nucleic Acid Detection Kit (Fluorescence PCR)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
C.difficile toxin a/b detection	W0105011802	Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. HWTS-EV032A3 réf.	B IVDR	Fiche EUDAMED Signaler une erreur
Candida albicans	W0105060302	Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Candida Albicans 50 tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Coronavirus / influenza - RT & POC	W0105090601	COVID-19/ Flu A&B Ag Rapid Test HWTS-RT200A3 réf.	C IVDR	Fiche EUDAMED Signaler une erreur
D-dimer	W0103020503	D-Dimer Test Kit (Fluorescence Immunoassay)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Enterovirus - NA reagents	W0105040502	Enterovirus Universal, EV71 and CoxA16 Nucleic Acid Detection Kit (Fluorescence PCR)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
H. pylori detection by NA reagents	W0105010403	Helicobacter Pylori and Toxin Nucleic Acid Detection Kit (Fluorescence PCR)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
HPV reagents - other	W0105041099	14 High-Risk HPV with 16/18 Genotyping Test Kit（Fluorescence PCR） 50 tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Immunochemistry readers	W0201020201	Macro & Micro-Test Fluorescence Immunoassay Analyzer HWTS IF 1003 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Influenza & para influenza - NA reagents	W0105040504	Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-RT176A3 réf.	B IVDR	Fiche EUDAMED Signaler une erreur
Interleukin 6 (il-6)	W01030609	IL-6 Test Kit (Fluorescence Immunoassay)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
IVD general use consumable devices - other	W0599	Sputasol 4×100mL/kit2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Mycoplasma pneumoniae detection by NA reagents	W010501080301	Mycoplasma Pneumoniae Nucleic Acid Detection Kit (Fluorescence PCR)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Nucleic acid testing instruments except micro-arrays - other	W02050199	Easy Amp Real-time Fluorescence Isothermal Detection System HWTS 1600P,HWTS 1600S2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Other virus combinations - multiplex NA reagents	W0105070302	Freeze-dried Six Respiratory Pathogens Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-RT177A3 réf.	B IVDR	Fiche EUDAMED Signaler une erreur
Plasmodium (malaria)	W0105050209	Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Plasmodium 50 tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	Jiangsu Macro & Micro-Test Med-Tech Co., Ltd Type Ⅰ: 50 tests/ kit3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Samples collection devices - other	W05019099	Macro & Micro-Test Sample Collecting, Mailing & Shipping Kit3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Screening high-risk HPV - NA reagents	W0105041002	15 Types of High-risk Human Papillomavirus E6/E7 Gene mRNA Detection Kit (Fluorescence PCR)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents	W0105070501	14 Kinds of Genitourinary Tract Infection Pathogen Nucleic Acid Detection Kit (Fluorescence PCR)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Streptococcal reagents - other	W0105011199	Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Group B Streptococcus 50 tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Various sample processing instruments - other	W02069099	Macro & Micro-Test Automatic Nucleic Acid Extractor HWTS-NPure32	A IVDR	Fiche EUDAMED Signaler une erreur

Un modèle enregistré dans EUDAMED n'est pas forcément commercialisé dans votre pays. Vérifiez la disponibilité et le marquage CE auprès du fabricant.

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