Manufacturer

Ustar Biotechnologies (Hangzhou)

ChinaLegal entities : Ustar Biotechnologies (Hangzhou) Ltd.

First countries of placing on the market declared in EUDAMED : France, Netherlands

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

28 categories, 75 models including 75 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
Samples collection devices - other	W05019099	Sample Collection and Preservation Medium U400079-20 Sample Collection and Preservation Medium U400090-20 Sample Preservation Solution U400010-100 Sample Preservation Solution U400011-100 Sample Preservation Solution U400037-100 16 others Sample Preservation Solution U400039-20 Sample Preservation Solution U400040-20 Sample Preservation Solution U400055-100 Sample Reagent U400059-20 Sample Reagent U400070-20 Sample Reagent U400077-20 Sample Reagent U400078-20 Sample Reagent U400081-10 Sample Reagent U400091-20 Sample Reagent U400093-103 refs Sample Reagent U400094-103 refs U400014-100 U400023-100 U400024-100 U400064-20 U400067-20	A IVDR	EUDAMED record Report an error
Nucleic acid testing apparatuses - rapid and point of care tests	W02050301	MultNAT Molecular Diagnostic Testing System MultNAT Molecular Diagnostic Testing System UP0102/UP01042 refs PortNAT Molecular Analyzer PN0102 UC0102 UC0104 7 others UC0108 UC0116 UC0204 UC0208 UC0216 UP0202 UP0204	A IVDR	EUDAMED record Report an error
Mycobacterial detection by NA reagents	W0105010703	EasyNAT MTC Assay EasyNAT MTC/NTM Assay98/79 MultNAT MTC Assay MultNAT MTC/MDR Assay98/79 MultNAT MTC/RIF Assay 3 others MultNAT MTC/XDR Assay98/79 MultNAT NTM Panel98/79 PortNAT TB Assay	C IVDR, 98/79	EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents	W0105070503	MultNAT Pneumonia Panel98/79 MultNAT Pneumonia Panel 22 refs98/79 MultNAT Respiratory Panel2 refs MultNAT Respiratory Panel 298/79	C IVDR, 98/79	EUDAMED record Report an error
Streptococcal detection by NA reagents	W0105011102	EasyNAT GBS Assay MultNAT GBS Assay MultNAT Strep A Assay98/79	C IVDR, 98/79	EUDAMED record Report an error
Bordetella pertussis / parapertussis - NA reagents	W0105011607	EasyNAT BP Assay EasyNAT BP erythromycin Resistance Assay98/79	C IVDR, 98/79	EUDAMED record Report an error
Meningitis / encephalitis infections - multiplex NA reagents	W0105070505	MultNAT Meningitis Encephalitis Panel98/79 MultNAT STI Panel	C IVDR, 98/79	EUDAMED record Report an error
Reagents for DNA and/or RNA amplification and/or detection: bacteria and/or virus	W0105900102	Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real Time Fluorescence Assay)98/79 EasyNAT Vibrio Cholerae Assay98/79	– 98/79	EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents	W0105070501	EasyNAT CT/NG Assay MultNAT Sexually Transmitted Infections Panel3 refs98/79	C IVDR, 98/79	EUDAMED record Report an error
Blood stream infection/sepsis (bacteria & fungi) - multiplex NA reagents	W0105070202	MultNAT Blood Culture Identification Panel2 refs98/79	– 98/79	EUDAMED record Report an error
C.difficile by NA reagents	W0105011804	MultNAT C.difficile Assay	B IVDR	EUDAMED record Report an error
Enterovirus - NA reagents	W0105040502	MultNAT EV Assay	C IVDR	EUDAMED record Report an error
Gastrointestinal infections - multiplex NA reagents	W0105070504	MultNAT Gastrointestinal Panel4 refs	B IVDR, 98/79	EUDAMED record Report an error
H. pylori detection by NA reagents	W0105010403	Helicobacter pylori 23S rRNA Gene mutation Detection Kit98/79	– 98/79	EUDAMED record Report an error
Hsv - NA reagents	W0105040311	EasyNAT HSV 1&2 Assay	C IVDR	EUDAMED record Report an error
Influenza & para influenza - NA reagents	W0105040504	EasyNAT Rapid Flu Assay	B IVDR	EUDAMED record Report an error
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents	W0105070304	MultNAT SARS-CoV-2/Flu and RSV PCR Assay	B IVDR	EUDAMED record Report an error
Legionella detection by NA reagents	W0105010503	EasyNAT LP Assay98/79	– 98/79	EUDAMED record Report an error
Monkeypox virus / mpox - NA reagent	W0105040532	MultNAT Monkeypox Virus Assay98/79	– 98/79	EUDAMED record Report an error
Mycoplasma pneumoniae detection by NA reagents	W010501080301	EasyNAT MP Assay	C IVDR	EUDAMED record Report an error
Norovirus - NA reagents	W0105040516	MultNAT Norovirus Assay98/79	– 98/79	EUDAMED record Report an error
Other HPV - NA reagents	W0105041005	MultNAT HPV Panel2 refs98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria)	W0105050209	EasyNAT Malaria Assay98/79	– 98/79	EUDAMED record Report an error
Respiratory syncytial virus (rsv) - NA reagents	W0105040505	EasyNAT Rapid RSV Assay	B IVDR	EUDAMED record Report an error
Staphylococcal detection by NA reagents	W0105011203	MultNAT MRSA/SA Assay	C IVDR	EUDAMED record Report an error
Syphilis detection by NA reagents	W0105010305	EasyNAT TP Assay98/79	– 98/79	EUDAMED record Report an error
Tropical fever - multiplex NA reagents	W0105070506	MultNAT Tropical Fever Panel3 refs	C IVDR	EUDAMED record Report an error
Virology - NA reagents - other	W0105040599	EasyNAT Monkeypox Virus Assay98/79	– 98/79	EUDAMED record Report an error

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