Manufacturer

Synthgene (Yixing) Health Technology

ChinaLegal entities : Synthgene (Yixing) Health Technology Co., Ltd.

Markets : Germany

EU representative : MedPath GmbH (Germany)

14 categories, 27 models including 27 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
Gram+ - gram- - fungi - multiplex assays	W0105070203	Bacterial vaginosis Rapid Test Kit (Colloidal gold method)98/79 Candida Albicans Antigen Rapid Test Kit (Colloidal gold method)98/79 Neisseria Gonorrhoeae Antigen Rapid Test Kit(Colloidal gold method)98/79 Trichomonas Vaginalis Antigen Rapid Test Kit (Colloidal gold method)98/79 Trichomonas/Candida Antigen Combo Rapid Test Kit (Colloidal gold method)98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria)	W0105050209	Malaria Antibody Rapid Test Kit (Colloidal gold method)98/79 Malaria Antigen Rapid Test Kit (Colloidal gold method)98/79 Malaria pf/pan Rapid Test Kit(Colloidal gold method)98/79 Malaria pf/pv Antigen Rapid Test Kit (Colloidal gold method)98/79	– 98/79	EUDAMED record Report an error
Dengue virus	W0105040611	Dengue IgG/IgM Rapid Test Kit (Colloidal gold method)98/79 Dengue IgG/IgM/NS1 Rapid Test Kit (Colloidal gold method)98/79 Dengue NS1 Rapid Test Kit (Colloidal gold method)98/79	– 98/79	EUDAMED record Report an error
Multiple viruses - multiplex assays - other	W0105070399	COVID-19/Influenza A+B Antigen Combo Rapid Test Kit(Colloidal gold method)98/79 COVID-19/Influenza(A+B)/RSV Antigen Combo Rapid Test Kit(Colloidal gold method)98/79 SARS-COV-2 Nucleocapsid(N) Antigen Rapid Detection kit (Colloidal gold method))98/79	– 98/79	EUDAMED record Report an error
Bacteriology - RT & POC - other	W0105090199	Typhoid Antigen Rapid Test Kit (Colloidal gold method)98/79 Typhoid IgG/IgM Rapid Test Kit (Colloidal gold method)98/79	– 98/79	EUDAMED record Report an error
Monkeypox virus / mpox RT & POC	W0105099008	Monkeypox Virus Antibody Rapid Test Kit CR01598/79 Monkeypox Virus Antigen Rapid Test Kit CR01798/79	– 98/79	EUDAMED record Report an error
H. pylori antibody assays	W0105010402	H. Pylori Antibody Rapid Test Kit(Colloidal gold method)98/79	– 98/79	EUDAMED record Report an error
H. pylori antigen detection	W0105010401	H. Pylori Antigen Rapid Test Kit CR00798/79	– 98/79	EUDAMED record Report an error
HPV antigen / antibodies	W0105041001	HPV Rapid Test kit FK00698/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	FluA/FluB Antigen Rapid Test Kit (Colloidal gold method)98/79	– 98/79	EUDAMED record Report an error
Rsv - RT & POC	W0105099002	RSV Antigen Rapid Test Kit(Colloidal gold method)98/79	– 98/79	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	Strep A Antigen Rapid Test Kit (Colloidal gold method)98/79	– 98/79	EUDAMED record Report an error
Strep. b - RT & POC	W0105090104	Strep B Antigen Rapid Test Kit(Colloidal gold method)98/79	– 98/79	EUDAMED record Report an error
Syphilis antibody assays total	W0105010302	Syphilis (TP) Antibody Rapid Test Kit98/79	– 98/79	EUDAMED record Report an error

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