Manufacturer

Zhejiang Greylynx Biotech

ChinaLegal entities : Zhejiang Greylynx Biotech Co., Ltd.

Markets : Italy · Poland

Approvals : EU – class C

EU representative : Lotus NL B.V. (Netherlands)

info@vivachek.com

35 categories, 87 models including 87 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
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Category	EMDN code	Registered models	Class	Contact
Virology - RT & POC - other	W0105099099	Adenovirus Rapid Test GIADVg98/79 Astrovirus Rapid Test GIASV98/79 HSV 1/2 IgG Rapid Test GIHSV1/2G98/79 HSV 1/2 IgG/IgM Combo Rapid Test GIHSV1/298/79 HSV 1/2 IgG/IgM Rapid Test GIHSV1/298/79 6 others HSV 1/2 IgM Rapid Test GIHSV1/2m98/79 Mycoplasma pneumoniae Ag Rapid GIMPg98/79 Mycoplasma pneumoniae IgM Rapid Test GIMPm98/79 Norovirus GI/GII Rapid Test GINOV98/79 Norovirus GI/GII Test GINOV98/79 Rotavirus Test GIROTA98/79	– 98/79	EUDAMED record Report an error
Multiple infectious - multiplex assays - other	W0105070599	Adenovirus/RSV/Influenza A+B Combo Rapid Test GIARF98/79 Influenza A/B Rapid Test GIFLU98/79 Multiplex Respiratory Antigen Combo Rapid Test GINRAA98/79 Multiplex Respiratory Antigen Combo Rapid Test GISFRAM98/79 Norovirus/Rotavirus/Adenovirus Combo Rapid Test GINRA98/79 5 others Rotavirus/Adenovirus Combo Test GINRA98/79 RSV/Influenza A+B Combo Rapid Test GIRF98/79 SARS-CoV-2/Flu A/Flu B Ag Rapid Test GISF98/79 SARS-CoV-2/Influenza A+B/RSV Ag Combo Rapid Test GISFR98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Ag Combo Rapid Test GISFRA98/79	– 98/79	EUDAMED record Report an error
Bacteriology - RT & POC - other	W0105090199	Campylobacter Rapid Test GICB98/79 Campylobacter Test GICB98/79 Gonorrhea Rapid Test GIGON98/79 Leptospira IgG/IgM Rapid Test GILEPb98/79 Lyme IgG/IgM Rapid Test GILygm98/79 1 other S.pneumoniae/L.pneumoohila Combo Rapid Test GISL98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Malaria P.f. Rapid Test GIMALf98/79 Malaria P.f./P.v. Rapid Test GIMALfv98/79 Malaria P.f./P.v./Pan Rapid Test GIMP98/79 Malaria P.f./Pan Rapid Test GIMALfa98/79 Malaria Pf/Pan Ag 4 Species Rapid Test GIMAL498/79	– 98/79	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	Dengue IgG/IgM and NS1 Combo Rapid Test GIDEN98/79 Dengue IgG/IgM and NS1 Combo Test GIDEN98/79 Dengue IgG/IgM Rapid Test GIDENb98/79 Dengue NS1 Ag Rapid Test GIDENg98/79	– 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	H. pylori Ab Rapid Test GIHPb98/79 H. pylori Ab Test GIHPb98/79 H. pylori Ag Rapid Test GIHPg98/79 H. pylori Ag Test GIHPg98/79	– 98/79	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	Strep A plus Rapid Test GIST98/79 Strep A Rapid Test GIST98/79 Strep A Rapid Test GISTA-702H3 refs Strep A Rapid Test(Control Line in Red) GIST98/79	C IVDR, 98/79	EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC	W0105090501	SARS-CoV-2 Ag Rapid Test GISARSg98/79 SARS-CoV-2 Ag Saliva Rapid Test GISARSg98/79 SARS-CoV-2 IgM/IgG Rapid Test GISARSgm98/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Influenza A Rapid Test GIFLUA98/79 Influenza A+B Rapid Test GIFLU98/79 Mononucleosis Rapid Test GIMONO98/79	– 98/79	EUDAMED record Report an error
Zika virus	W0105040630	Zika IgG/IgM Rapid Test GIZGM98/79 Zika IgG/IgM/NS1 Combo Rapid Test GIZGMN98/79 Zika NS1 Rapid Test GIZNS198/79	– 98/79	EUDAMED record Report an error
Chikungunya virus	W0105040625	Chikungunya IgG/IgM Rapid Test GICHK98/79 Chikungunya IgM Rapid Test GICHKm98/79	– 98/79	EUDAMED record Report an error
D-dimer	W0103020503	D-Dimer Rapid Test GCDDM98/79 D-Dimer Test GCDDM98/79	– 98/79	EUDAMED record Report an error
Enterovirus	W0105040602	Enterovirus Rapid Test GIHEV98/79 EV71 IgM Rapid Test GIEV7198/79	– 98/79	EUDAMED record Report an error
Giardia lamblia	W0105050208	Giardia Lamblia Rapid Test GIGIL98/79 Giardia Rapid Test GIGI98/79	– 98/79	EUDAMED record Report an error
Hav antibody (total)	W0105020102	HAV IgG/IgM Rapid Test GIHAVb98/79 HAV IgG/IgM Test GIHAVb98/79	– 98/79	EUDAMED record Report an error
Hev antibody igm	W0105020505	HEV IgG/IgM Rapid Test GIHEV98/79 HEV IgM Rapid Test GIHEVm98/79	– 98/79	EUDAMED record Report an error
Legionella - RT & POC	W0105090108	Legionella Pneumophila Rapid Test GILeg98/79 Legionella Rapid Test GILeg98/79	– 98/79	EUDAMED record Report an error
Mononucleosis (ebv) - RT & POC	W0105099003	MONO Rapid Test GIMONO98/79 Mononucleosis Test GIMONO98/79	– 98/79	EUDAMED record Report an error
Mycobacterial antibody assays	W0105010702	Tuberculosis IgG/IgM Rapid Test GITBb98/79 Tuberculosis IgG/IgM Test GITBb98/79	– 98/79	EUDAMED record Report an error
C.difficile GDH and toxin a/b combined detection	W0105011803	C. difficile Toxin A/B+GDH Rapid Test GICD98/79	– 98/79	EUDAMED record Report an error
C.difficile GDH detection	W0105011801	C. difficile GDH Ag Rapid Test GICDG98/79	– 98/79	EUDAMED record Report an error
Chagas	W0105050202	Chagas Ab Rapid Test GICA98/79	– 98/79	EUDAMED record Report an error
Clost. diff. incl GDH and/or toxin a and b - RT & POC	W0105090106	C. difficile Toxin A/B Rapid Test GICD98/79	– 98/79	EUDAMED record Report an error
Gonococcal antibody assays total	W0105010202	Gonorrhea Test GIGON98/79	– 98/79	EUDAMED record Report an error
Hav antibody igm	W0105020104	HAV IgM Rapid Test GIHAVm98/79	– 98/79	EUDAMED record Report an error
Multiple parasites panels	W01050704	Filariasis IgG/IgM Rapid Test GIFIb98/79	– 98/79	EUDAMED record Report an error
Other multiple pathogens - RT & POC	W0105090699	Rota/Adeno Ag Rapid Test GIRA98/79	– 98/79	EUDAMED record Report an error
Rsv - RT & POC	W0105099002	RSV Rapid Test GIRSV98/79	– 98/79	EUDAMED record Report an error
Salmonella antibody assays	W0105011002	Typhoid IgG/IgM Rapid Test GITYPb98/79	– 98/79	EUDAMED record Report an error
Salmonella antigen detection	W0105011001	Typhoid Ag Rapid Test GITYAg98/79	– 98/79	EUDAMED record Report an error
Strep. b - RT & POC	W0105090104	Strep B Rapid Test GISTB98/79	– 98/79	EUDAMED record Report an error
Strep. pneumoniae - RT & POC	W0105090109	S.pneumoniae Rapid Test GISPNE98/79	– 98/79	EUDAMED record Report an error
Syphilis - RT & POC	W0105090105	Syphilis Rapid Test GISY98/79	– 98/79	EUDAMED record Report an error
Tetanus (clostridium t.)	W0105011709	Tetanus Rapid Test GITET98/79	– 98/79	EUDAMED record Report an error
Virology reagents - other	W01050499	Adenovirus/RSV Combo Rapid Test GIADR98/79	– 98/79	EUDAMED record Report an error

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