Manufacturer

Genes2Me

IndiaLegal entities : Genes 2Me Private Limited

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

EU representative : Obelis s.a. (Belgium)

38 categories, 67 models including 67 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
Mycobacterial detection by NA reagents	W0105010703	Med4Me Tuberculosis Panel G2MMAP1000198/79 MTB-NTM Multiplex Real-Time PCR Kit G2M70742198/79 MTB-NTM Multiplex Real-Time PCR Kit G6100153 refs98/79 MTC-Q Real-Time PCR Kit G2M70732198/79 MTC-Q Real-Time PCR Kit G6100143 refs98/79 4 others TB NGS Test Kit G71001011 refs98/79 TB-Q Comprehensive Real Time PCR Kit for Tuberculosis G2M80312198/79 TB-Q Comprehensive Real Time PCR Kit for Tuberculosis G6100343 refs98/79 W0105010703 G71001098/79	– 98/79	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	MagNXT FFPE DNA Extraction Kit G2M8100073 refs MagNXT Tissue & body fluids Nucleic acid extraction kit G2M2121213 refs SpiNXT Cell free DNA Extraction Kit G2M8100132 refs SpiNXT FFPE DNA Extraction Kit G2M2321212 refs SpiNXT Tissue & body fluids Nucleic acid extraction kit G2M1314202 refs	A IVDR	EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents	W0105070501	CT/TV/NG Panel Real Time PCR kit G61002698/79 STI-Q comprehensive Real Time PCR Kit G2M80372198/79 STI-Q Core Real Time PCR Kit G61002698/79 STI-Q Real Time PCR kit G61002698/79 STI7-Q Real-Time PCR Kit G2M70912198/79	– 98/79	EUDAMED record Report an error
Blood stream infection/sepsis (bacteria & fungi) - multiplex NA reagents	W0105070202	Sepsi-AMR Real Time PCR kit G61002798/79 Sepsis-Q Real Time PCR Kit G2M804026,G2M804026R98/79 Sepsis-Q Real Time PCR Kit G61002798/79	– 98/79	EUDAMED record Report an error
Multiple infectious - multiplex assays - other	W0105070599	ctDNA Breast NGS Test Kit G71001198/79 LeoNext PanPathogen NGS Test Kit G71002112 refs98/79 LeoNext PP Library Prep Kit NGS310498/79	– 98/79	EUDAMED record Report an error
Mycoplasma / ureaplasma reagents - other	W0105010899	LP-MP Multiplex Real- Time PCR Kit G6100073 refs98/79 MDR-Q Real Time PCR Kit (Antimicrobial Resistance) G61001698/79 Sepsis-Q Real-Time PCR Kit G61002798/79	– 98/79	EUDAMED record Report an error
Virology - NA reagents - other	W0105040599	J.encephalitis -Q Real Time PCR Kit for Japanese encephalitis G2M80202198/79 MERS-Q Real Time PCR Kit for Middle East Respiratory Syndrome G2M80212198/79 Nipah-Q Real-Time PCR Kit G2M70592198/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents	W0105070304	CoVFlu One Step RT PCR Kit G2M27272198/79 RCP-Q comprehensive Real Time PCR Kit for Respiratory G2M80352198/79	– 98/79	EUDAMED record Report an error
Nucleic acid testing apparatuses - rapid and point of care tests	W02050301	One PCR Ultra-Fast RT PCR System IG2M5001UF Rapi Q HT - Micro RT PCR System IG2M50012 refs	A IVDR	EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - other	W02050199	RapiCycler 96 Real Time PCR System (4-Channel) G2MRAPI4001 RapiCycler 96 Real Time PCR System-(6-Channel) G2MRAPI4002	A IVDR	EUDAMED record Report an error
Robotic sample processing systems - other	W02060199	Rapi-X 16 Automated Nucleic Acid Extraction System G2MI80002 Rapi-X 96 Automated Nucleic Acid Extraction System G2MI80001	A IVDR	EUDAMED record Report an error
Tropical fever - multiplex NA reagents	W0105070506	Para-Q Multiplex Real Time PCR kit G2M70612198/79 Para2-Q Real Time PCR Kit G2M80152198/79	– 98/79	EUDAMED record Report an error
Adenovirus - NA reagents	W0105040501	Adeno-Q Real-Time PCR Kit G2M70782198/79	– 98/79	EUDAMED record Report an error
Bk virus - NA reagents	W0105040522	BK-Q Real Time PCR Kit for BK virus G2M70542198/79	– 98/79	EUDAMED record Report an error
Candida albicans - NA reagents	W0105060402	C. Albicans-Q Real- Time PCR Kit G2M70802198/79	– 98/79	EUDAMED record Report an error
Chagas	W0105050202	RapiT.Cruzi Rapid Antibody Test kit for Trypanosoma cruzi G2MR17255098/79	– 98/79	EUDAMED record Report an error
Chikungunya virus - NA reagents	W0105040525	Chikungunya-Q Real- Time PCR Test Kit G2M70532198/79	– 98/79	EUDAMED record Report an error
Dengue virus - NA reagents	W0105040511	DENGUE-Q Real Time PCR Kit G2M70502198/79	– 98/79	EUDAMED record Report an error
Ebv - NA reagents	W0105040403	EBV-Q Real Time PCR Kit G2M70562198/79	– 98/79	EUDAMED record Report an error
Full genotyping high-risk + low-risk HPV - NA reagents	W0105041004	HPV-Q comprehensive Real Time PCR Kit G2M80392198/79	– 98/79	EUDAMED record Report an error
Gastrointestinal infections - multiplex NA reagents	W0105070504	GCP-Q comprehensive Real Time PCR Kit for Gastrointestinal G2M80362198/79	– 98/79	EUDAMED record Report an error
Gonococcal detection by NA reagents	W0105010203	N. Gonorrhoeae-Q Real-Time PCR Kit G2M70642198/79	– 98/79	EUDAMED record Report an error
H. pylori detection by NA reagents	W0105010403	H. Pylori-Q Real-Time PCR Kit G2M706321,G2M706321R98/79	– 98/79	EUDAMED record Report an error
Hsv - NA reagents	W0105040311	HSV-Q Real-Time PCR Test Kit for Herpes simplex Virus 1 & 2 G2M70522198/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Influenza A/B-Q Real Time PCR Kit G2M70602198/79	– 98/79	EUDAMED record Report an error
Measles - NA reagents	W0105040704	Measles-Q Real Time PCR Kit G2M70572198/79	– 98/79	EUDAMED record Report an error
Meningitis / encephalitis infections - multiplex NA reagents	W0105070505	MCP-Q comprehensive Real Time PCR Kit for Meningitis G2M80382198/79	– 98/79	EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents	W0105041003	HPV-Q Real-Time PCR Kit G2M70672198/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria)	W0105050209	RapiMal Rapid Antigen Test kit for Malaria G2MR17251798/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Malaria-Q Real-Time PCR Kit G2M70622198/79	– 98/79	EUDAMED record Report an error
Respiratory syncytial virus (rsv)	W0105040605	RSV-Q Real Time PCR Kit G2M80122198/79	– 98/79	EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents	W0105070503	Comprehensive Respiratory Virus Panel G2MCRVP1700198/79	– 98/79	EUDAMED record Report an error
Rotavirus - NA reagents	W0105040506	Rota-Q Real Time PCR Kit for Rotavirus G2M80162198/79	– 98/79	EUDAMED record Report an error
Syphilis antibody assays total	W0105010302	RapiSyph Rapid Antibody Test kit for Syphilis G2MR17251598/79	– 98/79	EUDAMED record Report an error
Syphilis detection by NA reagents	W0105010305	Syphilis-Q Real Time PCR Kit G2M70552198/79	– 98/79	EUDAMED record Report an error
Vzv - RT & POC	W0105099006	VZV-Q Real-Time PCR Kit for Varicella-zoster virus G2M70582198/79	– 98/79	EUDAMED record Report an error
West nile virus - NA reagent	W0105040526	W. Nile-Q Real Time PCR Kit for West Nile Virus G2M80232198/79	– 98/79	EUDAMED record Report an error
Zika virus - NA reagents	W0105040531	ZikaQ Real Time PCR Kit for Zika Virus G2M26262198/79	– 98/79	EUDAMED record Report an error

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