Manufacturer

Wizbiotech

ChinaLegal entities : Xiamen Wiz Biotech Co., Ltd.

Markets : Belgium · Germany · Italy · Poland

Approvals : EU – class A

EU representative : QbD RepS BV (Belgium)

16 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
Coronavirus antigen (ag) - RT & POC	W0105090501	SARS-CoV-2 Antigen Rapid Test98/79 SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)98/79 SARS-CoV-2 Antigen Rapid Test (Saliva)98/79 SARS-CoV-2 Antigen Rapid Test (Sputum/Saliva/Stool)98/79 Type A, Type B98/79	– 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	Diagnostic Kit for Antibody Subtype to Helicobacter Pylori (Fluorescence Immunochromatographic Assay)98/79 Diagnostic Kit for Antibody to Helicobacter Pylori (Fluorescence Immunochromatographic Assay)98/79 Diagnostic Kit for Antibody to Helicobacter Pylori(Colloidal Gold)98/79 Diagnostic Kit for Antigen to Helicobacter Pylori (Fluorescence Immunochromatographic Assay)98/79 Diagnostic Kit for Antigen to Helicobacter Pylori (Latex)98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Malaria (P.F) Rapid Test (Colloidal Gold)98/79 Malaria P.F/P.V Rapid Test (Colloidal Gold)98/79 Malaria P.F/Pan Rapid Test(Colloidal Gold)98/79	– 98/79	EUDAMED record Report an error
Coronavirus antibody (ab) - RT & POC	W0105090502	SARS-CoV-2 Ab Rapid Test (Colloidal Gold)98/79 SARS-CoV-2 Neutralizing Antibodies Test98/79	– 98/79	EUDAMED record Report an error
Virology - RT & POC - other	W0105099099	Type A, Type B, Type C98/79 Type A, Type B.98/79	– 98/79	EUDAMED record Report an error
Adenovirus	W0105040601	Diagnostic Kit for Antigen to Adenoviruses (Colloidal Gold)98/79	– 98/79	EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)	W0201020102	WIZ-A101	A IVDR	EUDAMED record Report an error
Chlamydia pneumoniae antibody igm	W0105010116	Diagnostic Kit for IgM Antibody to C. pneumoniae(Colloidal Gold)98/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Type A, Type B, Type C98/79	– 98/79	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	Diagnostic Kit for Interleukin-6 (Fluorescence Immunochromatographic Assay)98/79	– 98/79	EUDAMED record Report an error
Mycoplasma antibody assays	W0105010802	Diagnostic Kit for IgM Antibody to Mycoplasma Pneumoniae (Colloidal Gold)98/79	– 98/79	EUDAMED record Report an error
Norovirus	W0105040616	Diagnostic Kit for Antigen to Norovirus (Colloidal Gold)98/79	– 98/79	EUDAMED record Report an error
Other multiple pathogens - RT & POC	W0105090699	Diagnostic Kit for Antigen to Rotavirus/Adenoviruses (Latex)98/79	– 98/79	EUDAMED record Report an error
Rotavirus	W0105040606	Diagnostic Kit for Antigen to Rotavirus (Latex)98/79	– 98/79	EUDAMED record Report an error
Rsv - RT & POC	W0105099002	Diagnostic Kit for Antigen to Respiratory Syncytial Virus (Colloidal Gold)98/79	– 98/79	EUDAMED record Report an error
Syphilis - RT & POC	W0105090105	Diagnostic Kit for Antibody to Treponema Pallidum(Colloidal Gold)98/79	– 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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