Manufacturer

Bosonbio

ChinaLegal entities : Xiamen Boson Biotech Co., Ltd.

First countries of placing on the market declared in EUDAMED : Croatia, France, Germany, Greece, Iceland, Italy, Lithuania, Poland, Romania, Slovenia, Spain, Sweden

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

Website

27 categories, 66 models including 66 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
Bacteriology - RT & POC - other	W0105090199	Rapid Leptospira IgG/IgM Combo Test 1O23C2-1-EU, 1O23C2-25-EU98/79 Rapid Rickettsia IgG/IgM Combo Test Card 1O06C298/79 Rapid Salmonella typhi Antigen Test Card 1O09C298/79 Rapid Salmonella typhi IgG/IgM Duo Test Card 1O04C298/79 Rapid Salmonella typhi/paratyphi Antigen Duo Test 1O13C298/79 4 others Rapid Tuberculosis Test Card-Serum 1O01C198/79 Rapid V. Cholerae O1 Test Strip 1O15S498/79 Rapid V.Cholerae O1/O139 Duo Test Card 1O17C498/79 Rapid V.Cholerae O139 Test Strip 1O16S498/79	– 98/79	EUDAMED record Report an error
Virology - RT & POC - other	W0105099099	Rapid Adeno/Rota Virus Antigen Combo Test Card 1N08C498/79 Rapid Adenovirus Antigen Test Card 1N06C498/79 Rapid HEV IgG/IgM Combo Test Card 1H26C298/79 Rapid HPIV Antigen Test98/79 Rapid HSV I&II IgG/IgM Combo Test 1N56C2-1-EU, 1N56C2-25-EU98/79 2 others Rapid Rotavirus Antigen Test Card 1N07C498/79 Rapid Rubella IgG/IgM Combo Test 1N50C2-1-EU, 1N50C2-25-EU98/79	– 98/79	EUDAMED record Report an error
Other multiple pathogens - RT & POC	W0105090699	Rapid Flu A+B/RSV Antigen Test Card98/79 Rapid Flu A+B/RSV/ADV Antigen Test Card98/79 Rapid SARS-CoV-2/Flu A+B/RSV Antigen Test Card 1N45C598/79 Rapid SARS-CoV-2/Flu A+B/RSV Antigen Test Card 1N45C5-198/79 Rapid SARS-CoV-2/Flu A+B/RSV/ADV Antigen Test Card 1N44C598/79 1 other Rapid SARS-CoV-2/Flu A+B/RSV/ADV Antigen Test Card 1N44C5-198/79	– 98/79	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	Dengue IgG/IgM Combo Test (FIA)98/79 Dengue NS1 Antigen Test (FIA)98/79 Rapid Dengue IgG/IgM Combo Test Card 1N04C298/79 Rapid Dengue NS1 Antigen and IgG/IgM Duo Panel Test Card 1N24C298/79 Rapid Dengue NS1 Antigen Test Card 1N23C298/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Rapid Malaria pan Antigen Test Card 1Q05C298/79 Rapid Malaria pf Antigen Test Card 1Q06C298/79 Rapid Malaria pf/pan Antigen Test Card 1Q10C298/79 Rapid Malaria pf/pv Antigen Test Card 1Q07C298/79	– 98/79	EUDAMED record Report an error
Coronavirus / influenza - RT & POC	W0105090601	Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card 1N41C5-1S-CE3 refs Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card 1N41C5-2598/79 Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card 1N41C5-2798/79	C IVDR, 98/79	EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC	W0105090501	Rapid SARS-CoV-2 Antigen Test Card3 refs Rapid SARS-CoV-2 Antigen Test Card 1N40C5-2598/79 SARS-CoV-2 Antigen Test (FIA)98/79	C IVDR, 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	Rapid H.Pylori Antibody Test Card 1O02C298/79 Rapid H.Pylori Antigen Test Card (3mm) 1O03C4298/79 Rapid H.Pylori Antigen Test Card 1O03C498/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Influenza A + B Antigen Test (FIA)98/79 Rapid Influenza A Antigen Test Card 1N17C598/79 Rapid Influenza A+B Antigen Test Card 1N18C598/79	– 98/79	EUDAMED record Report an error
D-dimer - RT & POC	W0103020803	D-Dimer Test (FIA)98/79 Rapid D-Dimer Test Card 1M21C298/79	– 98/79	EUDAMED record Report an error
Rsv - RT & POC	W0105099002	Rapid Respiratory Syncytial Virus Antigen Test Card 1N26C598/79 Respiratory Syncytial Virus Antigen Test (FIA)98/79	– 98/79	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	Rapid Strep A Test Card 1O08C598/79 Rapid Strep A Test Card 1O08C5-198/79	– 98/79	EUDAMED record Report an error
Syphilis - RT & POC	W0105090105	Rapid Syphilis Antibody Test Card 1N02C298/79 Rapid Syphilis Antibody Test Strip 1N02S298/79	– 98/79	EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - other	W0201069099	Colloidal Gold Immunoassay Analyzer Fluorescence Immunoassay Analyzer3 refs	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	Chemiluminescence Immunoassay Analyzer2 refs	A IVDR	EUDAMED record Report an error
Chikungunya virus	W0105040625	Rapid Chikungunya IgG/IgM Combo Test Card 1N27C298/79	– 98/79	EUDAMED record Report an error
Coronavirus antibody (ab) - RT & POC	W0105090502	SARS-CoV-2 Neutralizing Antibody Test Card 1N42C298/79	– 98/79	EUDAMED record Report an error
D-dimer	W0103020503	D-Dimer assay (CLIA)98/79	– 98/79	EUDAMED record Report an error
H. pylori antibody assays	W0105010402	Helicobacter Pylori IgG assay (CLIA)98/79	– 98/79	EUDAMED record Report an error
Hav antibody (total)	W0105020102	Rapid HAV IgG/IgM Combo Test Card 1H16C298/79	– 98/79	EUDAMED record Report an error
Legionella - RT & POC	W0105090108	Rapid Legionella Urinary Antigen Test Card 1O05C398/79	– 98/79	EUDAMED record Report an error
Mycoplasma antigen detection	W0105010801	Rapid Mycoplasma Pneumoniae Antigen Test 1O26C5-1-EU,1O26C5-20-EU98/79	– 98/79	EUDAMED record Report an error
Plasmin - a2 - antiplasmin complex	W0103020305	PIC assay (CLIA)98/79	– 98/79	EUDAMED record Report an error
Special coagulation tests - other	W0103020399	Thrombomodulin assay (CLIA)98/79	– 98/79	EUDAMED record Report an error
Syphilis antibody assays total	W0105010302	Treponema Pallidum Antibody assay (CLIA)98/79	– 98/79	EUDAMED record Report an error
Thrombin-antithrombin III-complex	W0103020307	Thrombin-Antithrombin III Complex assay (CLIA)98/79	– 98/79	EUDAMED record Report an error
Zika virus	W0105040630	Rapid Zika Virus IgG/IgM Combo Test Card 1N28C298/79	– 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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