Manufacturer

Gensurebio

ChinaLegal entities : GenSure Biotech Inc.

Markets : Austria · Croatia · Cyprus · Germany · Greece · Italy · Poland · Spain

Approvals : EU – class C

EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)

Website info@gensurebio.com

21 categories, 43 models including 43 on the market, 1 country

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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
Other multiple pathogens - RT & POC	W0105090699	Candida Albicans/Gardnerella Vaginalis/Trichomonas Vaginalis Ag Rapid Test P203298/79 COVID-19/Flu A+B/RSV/hMPV Ag Rapid Test P209798/79 COVID-19/Flu A+B/RSV/Radv/M.p Ag Rapid Test P209698/79 COVID-19/FluA+B/RSV/Radv/hMPV/M.p Ag Rapid Test P208598/79 COVID-19/FluA+B/RSV/Radv/hMPV/M.p/PIV Ag Rapid Test P208898/79 9 others COVID-19/FluA+B/RSV/Radv/hMPV/PIV/hRV Ag Rapid Test P208798/79 COVID-19/RSV/Flu A+B Ag Rapid Test P2081C01, P2081C02, P2081C05, P2081C20.3 refs COVID-19/RSV/Radv/Flu A/B Ag Rapid Test P203998/79 COVID-19/RSV/Radv/hMPV/Flu A+B Ag Rapid Test P208498/79 COVID-19/RSV/Radv/M.P/hMPV/hRV/Flu A+B Ag Rapid Test P208698/79 COVID19/FluA+B/RSV+Radv/hMPV+hRV/PIV/M.p Ag Rapid Test P208998/79 RSV/Radv/Flu A+B Antigen Rapid Test P209098/79 Strep A/COVID-19 Antigen Rapid Test P230398/79 Strep A/COVID-19/Flu A+B Ag Rapid Test P230498/79	C IVDR, 98/79	EUDAMED record Report an error
Multiple viruses - multiplex assays - other	W0105070399	GenSure Rotavirus/Adenovirus/Norovirus Combo Rapid Test P240198/79 Rotavirus/Adenovirus Combo Rapid Test P202498/79 Rotavirus/Adenovirus/Norovirus Combo Rapid Test P240198/79 Rotavirus/Adenovirus/Norovirus/Astrovirus Combo Rapid Test P240398/79	– 98/79	EUDAMED record Report an error
Clost. diff. incl GDH and/or toxin a and b - RT & POC	W0105090106	C.difficile GDH + Toxin A/B Combo Rapid Test P240898/79 C.difficile GDH Rapid Test P240998/79 C.difficile Toxin A/B Rapid Test P241098/79	– 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	H. pylori (HP) Ag Rapid Test P202098/79 H.pylori Ab (HP Ab) Rapid Test P202198/79	– 98/79	EUDAMED record Report an error
Parasites - RT & POC - other	W0105090499	Giardia Lamblia Ag Rapid Test P240598/79 Trichomonas Vaginalis (TV) Ag Rapid Test P203098/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Malaria P.f/P.v Antigen Rapid Test P204098/79 Malaria Pf/Pan Rapid Test P204198/79	– 98/79	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	DIAGOTEC Strep A Rapid Test3 refs Sinocare Strep A FIA KIT98/79	C IVDR, 98/79	EUDAMED record Report an error
Adenovirus	W0105040601	Adenovirus Ag Rapid Test P202398/79	– 98/79	EUDAMED record Report an error
Chikungunya virus	W0105040625	Chikungunya IgG/IgM Ab Rapid Test P205498/79	– 98/79	EUDAMED record Report an error
Coronavirus / influenza - RT & POC	W0105090601	COVID-19/Flu A+B Ag Rapid Test P2007C01, P2007C02, P2007C05, P2007C203 refs	C IVDR	EUDAMED record Report an error
Coronavirus antibody (ab) - RT & POC	W0105090502	COVID-19 IgG+IgM Rapid Test P200298/79	– 98/79	EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC	W0105090501	COVID-19 Ag Rapid Test P200498/79	– 98/79	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	Dengue Virus Ab Rapid Test P204298/79	– 98/79	EUDAMED record Report an error
Gonococcal antigen detection	W0105010201	Neisseria Gonorrhoeae Ag Rapid Test P204598/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	EuroGen Flu A+B Ag Rapid Test3 refs	C IVDR	EUDAMED record Report an error
Mycoplasma antibody assays	W0105010802	M. pneumoniae IgM/IgG Antibody Rapid Test P208298/79	– 98/79	EUDAMED record Report an error
Mycoplasma antigen detection	W0105010801	M. pneumoniae Antigen Rapid Test P208398/79	– 98/79	EUDAMED record Report an error
Norovirus	W0105040616	Norovirus Ag Rapid Test P202698/79	– 98/79	EUDAMED record Report an error
Rotavirus	W0105040606	Rotavirus Ag Rapid Test P202298/79	– 98/79	EUDAMED record Report an error
Rsv - RT & POC	W0105099002	Respiratory Syncytial Virus (RSV) Rapid Test P200898/79	– 98/79	EUDAMED record Report an error
Strep. b - RT & POC	W0105090104	Group B Streptococcus (GBS) Ag Rapid Test P202798/79	– 98/79	EUDAMED record Report an error

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