Manufacturer

Microprofit

ChinaLegal entities : Shenzhen Microprofit Biotech Co., Ltd

First countries of placing on the market declared in EUDAMED : Italy, Poland

EU representative : CMC Medical Devices & Drugs SL (Spain)

25 categories, 56 models including 56 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents	W0105070304	SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Control98/79 SARS-CoV-2 Antibody Test Kit (Colloidal Gold Chromatographic Immunoassay)98/79 SARS-CoV-2 Antibody Test Kit (Fluorescence Immunoassay)98/79 SARS-CoV-2 Antigen Test Control98/79 SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)(Saliva)98/79 7 others SARS-CoV-2 Antigen Test Kit (Fluorescence Immunoassay)98/79 SARS-CoV-2 IgG and IgM Antibody Combined Test Kit (Fluorescence Immunoassay)98/79 SARS-CoV-2 Neutralizing Antibody Test Kit (Colloidal Gold Chromatographic Immunoassay)98/79 SARS-CoV-2 Neutralizing Antibody Test Kit (Fluorescence Immunoassay)98/79 SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic Immunoassay)3 refs98/79 SARS-CoV-2 Spike Protein Test Kit (Fluorescence Immunoassay)98/79 SARS-CoV-2 IgG and IgM Antibody Combined Test Kit (Colloidal Gold Chromatographic Immunoassay)98/79	– 98/79	EUDAMED record Report an error
Other multiple pathogens - RT & POC	W0105090699	Respiratory 13 Pathogen Antigen Detection Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79 Respiratory 9 Pathogen Antigen Detection Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79 Respiratory Bacteria & M.P 6 Antigen Combo Test Kit (Immunochromatographic Assay)2 refs98/79 Respiratory Virus, Bacteria & M.P 10 Antigen Combo Test Kit (Immunochromatographic Assay)2 refs98/79 Respiratory Virus, Bacteria & M.p 11 Antigen Combo Test Kit (Immunochromatographic Assay)2 refs98/79 7 others Respiratory Virus, Bacteria & M.P 14 Antigen Combo Test Kit (Immunochromatographic Assay)2 refs98/79 SARS-CoV-2 & Influenza A/B & RSV /ADV/hMPV Antigen Combo Test Control98/79 SARS-CoV-2 & Influenza A/B & RSV/ADV/hMPV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79 SARS-CoV-2 & Influenza A/B Antigen Combo Test Kit(Colloidal Gold Chromatographic Immunoassay)98/79 SARS-CoV-2/RhV/PIV & Influenza A/B & RSV /ADV/hMPV Antigen Combo Test Control98/79 SARS-CoV-2/RhV/PIV & Influenza A/B & RSV/ADV/hMPV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79 SARS-CoV-2/RhV/PIV/Influenza A/B / RSV/ADV/hMPV/M.P Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79	– 98/79	EUDAMED record Report an error
Virology - RT & POC - other	W0105099099	SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit(Colloidal Gold Chromatographic Immunoassay)5 refs SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79 SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)（Saliva）3 refs98/79 self-diagnostics SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)3 refs98/79	C IVDR, 98/79	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	Dengue Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)4 refs98/79 Dengue IgG/IgM Antibody Combo Test Kit(Colloidal Gold Chromatographic Immunoassay)4 refs98/79	– 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	H.Pylori Antibody (H.p Ab) Diagnostic Kit (Immunochromatographic Assay)2 refs98/79 Helicobacter pylori Antigen (Hp-Ag) Diagnostic Kit (Immunochromatographic Assay)2 refs98/79	– 98/79	EUDAMED record Report an error
Immunochemistry instruments - other	W02010299	Dry-type Immunofluorescence Analyzer Dry-type Immunofluorescence Quantitative Analyzer MF-T1000	A IVDR	EUDAMED record Report an error
Optical laboratory microscopes	W0202050303	Fluorescent Biological Microscope Inverted Biological Microscope	A IVDR	EUDAMED record Report an error
Plasmodium (malaria)	W0105050209	Malaria Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)4 refs98/79 Malaria Pf/ Pv Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79	– 98/79	EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents	W0105070503	S.p/L.p/S.aureus/Kpn/M.P Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79 S.p/L.p/S.aureus/M.P Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79	– 98/79	EUDAMED record Report an error
Bacteriology - RT & POC - other	W0105090199	Candida Albicans Antigen Test Kit(Immunofluorescence)98/79	– 98/79	EUDAMED record Report an error
Bacteriology controls - inf.imm.	W0105080801	HP-Ag control98/79	– 98/79	EUDAMED record Report an error
D-dimer	W0103020503	D-dimer（DD) Diagnostic Kit (Immunochromatographic Assay)2 refs	C IVDR	EUDAMED record Report an error
Gonococcal antigen detection	W0105010201	N. Gonorrhea Test kit(Colloidal Gold Chromatographic Immunoassay)2 refs98/79	– 98/79	EUDAMED record Report an error
Haemostasis controls - other	W0103020799	D-dimer Control MF-234	C IVDR	EUDAMED record Report an error
Hsv 1 igg	W0105040306	Herpes Simplex Virus 1 IgG(HSV-1-IgG)Diagnostic Kit (Immunochromatographic Assay)2 refs98/79	– 98/79	EUDAMED record Report an error
Hsv 1 igm	W0105040307	Herpes Simplex Virus I IgM(HSV-I-IgM)Diagnostic Kit ( Immunochromatographic Assay)2 refs98/79	– 98/79	EUDAMED record Report an error
Hsv 2 antibodies - total	W0105040308	Herpes Simplex Virus-II (HSV-II) Antigen Test Kit(Immunofluorescence)98/79	– 98/79	EUDAMED record Report an error
Hsv 2 igg	W0105040309	Herpes Simplex Virus II IgG(HSV-II-IgG)Diagnostic Kit ( Immunochromatographic Assay)2 refs98/79	– 98/79	EUDAMED record Report an error
Hsv 2 igm	W0105040310	Herpes Simplex Virus II IgM(HSV-II-IgM)Diagnostic Kit ( Immunochromatographic Assay)2 refs98/79	– 98/79	EUDAMED record Report an error
Multiple viruses - multiplex assays - other	W0105070399	SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79	– 98/79	EUDAMED record Report an error
Other interleukins (except for il-6)	W01030606	Interleukin-6 (IL-6) Diagnostic Kit(Immunochromatographic Assay)2 refs98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Malaria Pf/ Pv Antigen Test Kit (Immunochromatographic Assay)2 refs98/79	– 98/79	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	Strep A antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79	– 98/79	EUDAMED record Report an error
Various general purpose IVD instruments - other	W02079099	Incubator MF-C100	A IVDR	EUDAMED record Report an error
Virology reagents - other	W01050499	MPxV Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79	– 98/79	EUDAMED record Report an error

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