Manufacturer

Nexlab

ChinaLegal entities : Nexlab Co., Ltd.

First countries of placing on the market declared in EUDAMED : France

EU representative : MedNet EC-REP GmbH (Germany)

15 categories, 28 models including 28 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
Plasmodium (malaria) - RT & POC	W0105090401	POCBio Malaria Pf Rapid Test LATT03-C2598/79 POCBio Malaria Pf Rapid Test LATT03-C5098/79 POCBio Malaria Pf/Pan Rapid Test LATT05-C2598/79 POCBio Malaria Pf/Pan Rapid Test LATT05-C5098/79 POCBio Malaria Pf/Pv Rapid Test LATT04-C2598/79 1 other POCBio Malaria Pf/Pv Rapid Test LATT04-C5098/79	– 98/79	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	POCBio Dengue IgM/IgG Rapid Test LATT02-C2598/79 POCBio Dengue IgM/IgG Rapid Test LATT02-C5098/79 POCBio Dengue NS1 and IgM/IgG Combo Rapid Test LATT07-C2598/79 POCBio Dengue NS1 Antigen Rapid Test LATT01-C2598/79 POCBio Dengue NS1 Antigen Rapid Test LATT01-C5098/79	– 98/79	EUDAMED record Report an error
H. pylori antibody assays	W0105010402	POCBio H.Pylori Antibody Rapid Test LATG01-C2598/79 POCBio H.Pylori Antibody Rapid Test LATG01-C5098/79	– 98/79	EUDAMED record Report an error
Other multiple pathogens - RT & POC	W0105090699	POCBio COVID-19/FluA/FluB/RSV 4 in 1 Rapid Test LATR05-C2598/79 POCBio Rota/Adenovirus Combo Rapid Test LATG03-C2598/79	– 98/79	EUDAMED record Report an error
Salmonella antibody assays	W0105011002	POCBio Typhoid IgM/IgG Rapid Test LATT06-C2598/79 POCBio Typhoid IgM/IgG Rapid Test LATT06-C5098/79	– 98/79	EUDAMED record Report an error
Syphilis - RT & POC	W0105090105	POCBio Syphilis Antibody Rapid Test LATB04-C2598/79 POCBio Syphilis Antibody Rapid Test LATB04-C5098/79	– 98/79	EUDAMED record Report an error
Coronavirus / influenza - RT & POC	W0105090601	POCBio COVID-19/Flu A&B Combo Rapid Test LATR04-C2598/79	– 98/79	EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC	W0105090501	POCBio SARS-CoV-2 Antigen Rapid Test LATR03-C2598/79	– 98/79	EUDAMED record Report an error
Gonococcal detection by NA reagents	W0105010203	Neisseria gonorrhoeae Real-time PCR Kit ITSZ09000198/79	– 98/79	EUDAMED record Report an error
H. pylori antigen detection	W0105010401	POCBio H.Pylori Antigen Rapid Test LATG02-C2598/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	POCBio Flu A/B Rapid Test LATR01-C2598/79	– 98/79	EUDAMED record Report an error
Mycobacterial antibody assays	W0105010702	POCBio Mycobacterium Tuberculosis (TB) Antibody Rapid Test LATR02-C5098/79	– 98/79	EUDAMED record Report an error
Salmonella antigen detection	W0105011001	POCBio S.Typhi/Paratyphi Ag Combo Rapid Test LATG04-C2598/79	– 98/79	EUDAMED record Report an error
Ureaplasma detection by NA reagents	W010501080303	Ureaplasma urealyticum Real-time PCR Kit ITSZ09200198/79	– 98/79	EUDAMED record Report an error
Urogenital mycoplasma detection by NA reagents	W010501080302	Mycoplasma hominis Real-time PCR Kit ITSZ09400198/79	– 98/79	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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