Manufacturer

Nanjing Synthgene Medical Technology

ChinaLegal entities : Nanjing Synthgene Medical Technology Co., Ltd.

Markets : Germany · Netherlands · United States

Approvals : EU – class A, C · United States (FDA) – 510(k) : 1 · class II · latest in 2025 · see on the FDA website

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

Website sales@syngenebio.com

19 categories, 28 models including 28 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 immunoassay - other	W0105011799	Bacterial vaginosis Rapid Test Kit (Colloidal gold method) CR02898/79 Typhoid Antigen Rapid Test Kit (Colloidal gold method) CR02198/79 Typhoid IgG/IgM Rapid Test Kit (Colloidal gold method) CR02098/79 Vibrio Cholerae O1 Rapid Test Kit (Colloidal gold method) CR03798/79 Vibrio Cholerae O1/O139 Rapid Test Kit (Colloidal gold method) CR03698/79	– 98/79	EUDAMED record Report an error
Infectious immunology - other	W0105900299	PCT/IL-6 Rapid Test Kit (Quantum Dot Fluorescence Immunoassay) CR04298/79 SAA/CRP Rapid Test Kit (Quantum Dot Fluorescence Immunoassay) CR04198/79 Trichomonas/Candida Antigen Combo Rapid Test Kit (Colloidal gold method) CR02798/79	– 98/79	EUDAMED record Report an error
D-dimer	W0103020503	D-Dimer Rapid Test Kit (Colloidal gold method) XJ00298/79 D-Dimer Rapid Test Kit (Quantum Dot Fluorescence Immunoassay) XJ00598/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria)	W0105050209	Malaria pf/pan Rapid Test Kit (Colloidal gold method) CR01898/79 Malaria pf/pv Antigen Rapid Test Kit (Colloidal gold method) CR00298/79	– 98/79	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	Strep A Antigen Rapid Test Kit (Colloidal gold method) CR02398/79 Strep B Antigen Rapid Test Kit (Colloidal gold method) CR02998/79	– 98/79	EUDAMED record Report an error
Adenovirus - NA reagents	W0105040501	Adenovirus Rapid Test Kit (Colloidal gold method) CR03598/79	– 98/79	EUDAMED record Report an error
Candida albicans	W0105060302	Candida Albicans Antigen Rapid Test Kit (Colloidal gold method) CR02598/79	– 98/79	EUDAMED record Report an error
Chikungunya virus - NA reagents	W0105040525	Chikungunya Fever IgG/IgM Antibody Test Kit (Colloidal Gold Method)98/79	– 98/79	EUDAMED record Report an error
Dengue virus	W0105040611	Dengue NS1 Rapid Test Kit (Colloidal gold method) CR02298/79	– 98/79	EUDAMED record Report an error
Giardia lamblia	W0105050208	Giardia Lamblia Rapid Test Kit (Colloidal gold method) CR03498/79	– 98/79	EUDAMED record Report an error
Gonococcal antigen detection	W0105010201	Neisseria Gonorrhoeae Antigen Rapid Test Kit (Colloidal gold method) CR02498/79	– 98/79	EUDAMED record Report an error
H. pylori antigen detection	W0105010401	H. Pylori Antigen Rapid Test Kit CR00705001HKS3 refs	C IVDR	EUDAMED record Report an error
Hsv antigen	W0105040301	HSV 12 Antigen Rapid Test Kit (Colloidal gold method) CR03098/79	– 98/79	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	IL-6 Rapid Test Kit (Quantum Dot Fluorescence Immunoassay) CR03898/79	– 98/79	EUDAMED record Report an error
Limited panel immunochemistry analysers - hardware accessories	W0201020280	HC-10 Portable Colloidal Gold Immunoassay Analyzer	A IVDR	EUDAMED record Report an error
Mycology immunoassays - other	W0105060399	Cryptococcal Antigen Rapid Test Kit (Colloidal gold method) CR01998/79	– 98/79	EUDAMED record Report an error
Rotavirus - NA reagents	W0105040506	Rotavirus Antigen Rapid Test Kit (Colloidal gold method) CR03298/79	– 98/79	EUDAMED record Report an error
Salmonella antigen detection	W0105011001	Salmonella Antigen Rapid Test Kit (Colloidal gold method) CR03398/79	– 98/79	EUDAMED record Report an error
Trichomonas	W0105050210	Trichomonas Vaginalis Antigen Rapid Test Kit (Colloidal gold method) CR02698/79	– 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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