Manufacturer

Shenzhen Chenghui Medical Technology

ChinaLegal entities : Shenzhen Chenghui Medical Technology Co., Ltd.

Markets : Italy

Approvals : EU – class A, B

EU representative : HUMISS TRADING S. L. (Spain)

9 categories, 17 models including 17 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
Respiratory tract infections - multiplex NA reagents	W0105070503	Lower Respiratory Tract Pathogen and Antimicrobial Resistance Gene Nucleic Acid Detection Kit 1.198/79 Respiratory Tract Pathogen Test Kit 2.198/79 Upper Respiratory Tract Pathogen Nucleic Acid Detection Kit (Fluorescent PCR-Chip Method)	B IVDR, 98/79	EUDAMED record Report an error
Blood stream infection/sepsis (bacteria & fungi) - multiplex NA reagents	W0105070202	Blood Culture Pathogen and Antimicrobial Resistance Gene (G+&Fungi&AMR) Nucleic Acid Detection Kit 1.198/79 Blood Culture Pathogen and Antimicrobial Resistance Gene (G-&AMR) Nucleic Acid Detection Kit 1.198/79	– 98/79	EUDAMED record Report an error
Chemistry instruments - other	W02010199	Flex-disc CH-0104 Multi-disc CQ-0404	A IVDR	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Malaria Pathogen Nucleic Acid Detection Kit 1.198/79 Malaria Pathogen Nucleic Acid Detection Kit 2.198/79	– 98/79	EUDAMED record Report an error
Screening high-risk HPV - NA reagents	W0105041002	Human Papillomavirus (HPV) Nucleic Acid Typing Detection Kit 1.198/79 Human Papillomavirus (HPV) Nucleic Acid Typing Detection Kit 2.198/79	– 98/79	EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents	W0105070501	Reproductive Tract Pathogen Nucleic Acid Detection Kit 2.198/79 Reproductive Tract Pathogen Nucleic Acid Detection Kit1.198/79	– 98/79	EUDAMED record Report an error
Tropical fever - multiplex NA reagents	W0105070506	Arboviral Pathogen Nucleic Acid Detection Kit 1.198/79 Arboviral Pathogen Nucleic Acid Detection Kit 2.198/79	– 98/79	EUDAMED record Report an error
Gastrointestinal infections - multiplex NA reagents	W0105070504	Gastrointestinal Tract Pathogen Nucleic Acid Detection Kit 1.198/79	– 98/79	EUDAMED record Report an error
Meningitis / encephalitis infections - multiplex NA reagents	W0105070505	Meningitis Pathogen Nucleic Acid Detection Kit 1.198/79	– 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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