Manufacturer

Daltonbio

ChinaLegal entities : Hangzhou Dalton BioSciences, Ltd.

Markets : Germany · Portugal · Spain

Approvals : EU – class C

EU representative : Medunion S.L. (Spain)

7 categories, 10 models including 9 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Influenza & para influenza - NA reagents	W0105040504	Influenza A Virus Nucleic Acid Detection Kit (Isothermal Amplification Method)98/79 Influenza B Virus Nucleic Acid Detection Kit (Isothermal Amplification Method)98/79	– 98/79	EUDAMED record Report an error
Other HPV - NA reagents	W0105041005	High Risk Human Papillomavirus (Type 16, 18) Nucleic Acid Detection Kit (Isothermal Amplification Method)98/79 Low Risk Human Papillomavirus (Type 6, 11) Nucleic Acid Detection Kit (Isothermal Amplification Method)98/79	– 98/79	EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents	W0105041003	DH3 High-Risk HPV DNA Test3 refs High Risk Human Papillomavirus (HPV) Genotyping System98/79 (no longer marketed)	C IVDR, 98/79	EUDAMED record Report an error
Gonococcal detection by NA reagents	W0105010203	Neisseria Gonorrhoeae Nucleic Acid Detection Kit (Isothermal Amplification Method)98/79	– 98/79	EUDAMED record Report an error
H. pylori antigen detection	W0105010401	Helicobacter Pylori Antigen Detection Kit (Immunochromatographic Method)98/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Influenza A/B Virus Antigen Detection Kit (Immunochromatographic Method)98/79	– 98/79	EUDAMED record Report an error
Syphilis - RT & POC	W0105090105	/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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