Manufacturer

Mpbio

Germany, SingaporeLegal entities : MP Biomedicals Asia Pacific Pte Ltd, MP Biomedicals Germany GmbH

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

EU representative : MP Biomedicals Germany GmbH (Germany)

24 categories, 45 models including 45 on the market, 2 countries

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
Coronavirus antigen (ag) - RT & POC	W0105090501	Rapid SARS-CoV-2 Antigen Test Card2 refs98/79 Rapid SARS-CoV-2 Antigen Test Card (1 Test Box)98/79 Rapid SARS-CoV-2 Antigen Test Card (1 test per box NL)98/79 Rapid SARS-CoV-2 Antigen Test Card (20 tests per box)98/79 Rapid SARS-CoV-2 Antigen Test Card (5 tests per box)98/79 3 others Rapid SARS-CoV-2 Antigen Test Card (5 tests per box, NL)98/79 Rapid SARS-CoV-2 Antigen Test Card (7 tests per box)98/79 Rapid SARS-CoV-2 Antigen Test Card (8 tests per box)98/79	– 98/79	EUDAMED record Report an error
Bacteriology - RT & POC - other	W0105090199	MP Diagnostics ASSURE TB Rapid Test98/79 Rapid V. cholerae O1 Test Card98/79 Rapid V. cholerae O1 Test Strip98/79 Rapid V.Cholerae O139 Test Card98/79 Rapid V.Cholerae O139 Test Strip98/79	– 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	MP Diagnostics ASSURE H. pylori Antigen Rapid Test98/79 MP Diagnostics ASSURE H. pylori Rapid Test98/79 Rapid H.pylori Antigen Test Card98/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Rapid Influenza A + B Antigen Test Card98/79 Rapid Influenza A Antigen Test Card98/79 Rapid SARS-CoV-2 Influenza A+B Antigen Duo Test Card98/79	– 98/79	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	Dengue NS1 Antigen Rapid Test98/79 MP Diagnostics MULTISURE® Dengue Ab/Ag Rapid Test98/79	– 98/79	EUDAMED record Report an error
H. pylori antibody assays	W0105010402	MP Diagnostics Helico Blot 2.198/79 MP Diagnostics Helico Blot 2.1 MP Diagnostic Helico Blot 2.198/79	– 98/79	EUDAMED record Report an error
Hbsag - RT & POC	W0105090201	MP Diagnostics HBsAg ELISA 4.1 23470-096 (96 wells)98/79 MP Diagnostics HBsAg ELISA 4.1 23470-480 (480 wells)98/79	– 98/79	EUDAMED record Report an error
HIV multiple ag/ab combi test	W0105030404	MP Diagnostics HIV Ag/Ab Combo ELISA 4.0 23040-09698/79 MP Diagnostics HIV Ag/Ab Combo ELISA 4.0 23040-48098/79	– 98/79	EUDAMED record Report an error
IVD instruments - other	W0299	AutoBlot System 36 AutoBlot System 48	A IVDR	EUDAMED record Report an error
Various sample processing instruments - hardware accessories	W02069080	MPure-32 aNAP System MPure-96 aNAP System	A IVDR	EUDAMED record Report an error
Coronavirus antibody (ab) - RT & POC	W0105090502	Rapid 2019-nCoV IgG/IgM Combo Test Card98/79	– 98/79	EUDAMED record Report an error
D-dimer - RT & POC	W0103020803	Diagnostic Kit for D-Dimer 07CTNL502598/79	– 98/79	EUDAMED record Report an error
Dengue virus	W0105040611	Rapid Dengue NS1 Antigen Test Card98/79	– 98/79	EUDAMED record Report an error
Hepatitis viruses - RT & POC - other	W0105090299	MP Diagnostics ASSURE HEV lgM Rapid Test98/79	– 98/79	EUDAMED record Report an error
Hev antibody (total)	W0105020503	MP Diagnostics HEV ELISA 4.098/79	– 98/79	EUDAMED record Report an error
Hev antibody igg	W0105020504	MP Diagnostics HEV ELISA98/79	– 98/79	EUDAMED record Report an error
Hev antibody igm	W0105020505	MP Diagnostics HEV lgM ELISA 3.098/79	– 98/79	EUDAMED record Report an error
HIV 1 / 2 - RT & POC	W0105090302	MP Diagnostics MULTISURE HIV Rapid Test98/79	– 98/79	EUDAMED record Report an error
HIV multiple antibody - confirmatory	W0105030403	MP Diagnostics MULTISURE HIV 1/2 Confirmatory Test98/79	– 98/79	EUDAMED record Report an error
Immunochemistry readers	W0201020201	Immunofluorescence Analyzer MPQuanti™	A IVDR	EUDAMED record Report an error
Infectious immunology instruments	W0204	AutoScan PRO 4.0	A IVDR	EUDAMED record Report an error
Retrovirus controls - inf.imm.	W0105080803	MP Diagnostics MULTISURE HIV 1/2 Confirmatory Test Controls98/79	– 98/79	EUDAMED record Report an error
Salmonella antibody assays	W0105011002	Rapid Salmonella typhi IgG/IgM Combo Test Card2 refs98/79	– 98/79	EUDAMED record Report an error
Zika virus	W0105040630	Rapid Zika Virus IgG/IgM Combo Test Card2 refs98/79	– 98/79	EUDAMED record Report an error

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