Manufacturer

Vazyme

ChinaLegal entities : Nanjing Vazyme Medical Technology Co.,Ltd.

First countries of placing on the market declared in EUDAMED : Belgium, Germany, Spain

EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)

23 categories, 47 models including 47 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
D-dimer	W0103020503	D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography) D2402CC98/79 D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography) D2402CL98/79 D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography) D2402CV98/79 D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography) D2403CC98/79 D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography) D2403CV98/79 1 other D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography) D2404CC98/79	– 98/79	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	Interleukin 6 (IL-6) Test Kit (Quantum Dots Fluorescence Immunochromatography) C4402CC98/79 Interleukin 6 (IL-6) Test Kit (Quantum Dots Fluorescence Immunochromatography) C4402CL98/79 Interleukin 6 (IL-6) Test Kit (Quantum Dots Fluorescence Immunochromatography) C4402CL, C4403CV, C4402CV, C4402CC, C4404CC, C4403CC98/79 Interleukin 6 (IL-6) Test Kit (Quantum Dots Fluorescence Immunochromatography) C4403CC98/79 Interleukin 6 (IL-6) Test Kit (Quantum Dots Fluorescence Immunochromatography) C4403CV98/79 1 other Interleukin 6 (IL-6) Test Kit (Quantum Dots Fluorescence Immunochromatography) C4404CC98/79	– 98/79	EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	Logilet Logicore System Real-Time Fluorescence Quantitative PCR System Turbo16 Real-Time Quantitative Thermal Cycler FMR3 Vazyme Hybrid System2 refs	A IVDR	EUDAMED record Report an error
All infectious diseases controls - NAT	W0105080808	Quality Control Kit for Logilet HPV Panel QC401198/79 Quality Control Kit for Logilet Respiratory Pathogen Panel Quality Control Kit for Logilet STl Panel QC402198/79	B IVDR, 98/79	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	DNA/RNA Extraction Kit RM301-013 refs High-throughput Virus DNA/RNA Nucleic Acid Extraction Kit RM502ME Universal DNA/RNA Extraction Kit ECM01ME-01	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	Fluorescence Immune Analyzer QD-S900 Quantum Dot Fluorescence Immune Analyzer QD-S600	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)	W0201020102	Automatic Chemiluminescence Immunoassay Analyzer Elf S260 , Elf S2902 refs Automatic Fluorescence Immunoassay Analyzer QD-S2000	A IVDR	EUDAMED record Report an error
Automated systems for the management of pre and post-analysis	W02060101	Automatic Nucleic Acids Extraction Instrument VNP-32YL Full-automatic Nucleic Acids Extraction Instrument VNP-96	A IVDR	EUDAMED record Report an error
Coronavirus - NA reagents	W0105041106	2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit CD302-0298/79 2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit CD312-0298/79	– 98/79	EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents	W0105070503	Logilet Respiratory Pathogen Panel VD101198/79 Logilet Respiratory/Sore Throat (R/ST) Test Panel DUR01M98/79	– 98/79	EUDAMED record Report an error
Screening high-risk HPV - NA reagents	W0105041002	Logilet HPV Panel VD401198/79 Logilet Hr-HPV Panel DHPV01M98/79	– 98/79	EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents	W0105070501	Logilet Sexual Health Test Panel DSTI01M98/79 Logilet STl Panel VD402198/79	– 98/79	EUDAMED record Report an error
Blood collection, tubes with additives or serum separator	W050101010201	Cell-Free DNA Collection Tube BH106ME-C1-XY、BH106ME-C12 refs	A IVDR	EUDAMED record Report an error
Coronavirus / influenza - RT & POC	W0105090601	SARS-CoV-2 and Influenza A/B Virus Antigen Combined Detection Kit (Colloidal Gold-Based)98/79	– 98/79	EUDAMED record Report an error
Coronavirus antibody (ab) - RT & POC	W0105090502	2019-nCoV IgG/IgM Detection Kit (Colloidal Gold-Based） C6603C98/79	– 98/79	EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC	W0105090501	Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) C8611C98/79	– 98/79	EUDAMED record Report an error
Gastrointestinal infections - multiplex NA reagents	W0105070504	Logilet Gastrointestinal Panel DGI02M98/79	– 98/79	EUDAMED record Report an error
Meningitis / encephalitis infections - multiplex NA reagents	W0105070505	Logilet Meningitis/Encephalitis Panel DME02M98/79	– 98/79	EUDAMED record Report an error
Mycobacterial detection by NA reagents	W0105010703	Logilet MTB/RIF Panel DTB01M98/79	– 98/79	EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - other	W02050199	High Throughput Fluorescence Quantimeter VNM-96SY1, VNM-96DY12 refs	A IVDR	EUDAMED record Report an error
Tropical fever - multiplex NA reagents	W0105070506	Logilet Arbovirus Panel DAB01M98/79	– 98/79	EUDAMED record Report an error
Various sample processing instruments - other	W02069099	Automated Liquid Handling Workstation VNL-96	A IVDR	EUDAMED record Report an error
Virology - NA reagents - other	W0105040599	Novel Coronavirus (SARS-CoV-2) and Influenza A/B Virus RT-qPCR Detection Kit98/79	– 98/79	EUDAMED record Report an error

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