Manufacturer

Neo-nostics (Suzhou) Bioengineering

ChinaLegal entities : Neo-nostics (Suzhou) Bioengineering Co., Ltd.

Markets : Germany · Spain

EU representative : Medunion S.L. (Spain)

6 categories, 26 models including 26 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
Bacteriology - RT & POC - other	W0105090199	Brucella Antibody Test Kit(Serum/plasma/whole blood) BRU004898/79 E.coli O157 Test Kit(Feces) ECO005798/79 H.pylori Antibody Test Kit(Serum/plasma/whole blood) HPB002098/79 H.pylori Antigen Test Kit(Feces) HPG002198/79 Leptospira lgG/lgM Test Kit(Serum/plasma/whole blood) LEP013098/79 6 others Scrub Typhus IgG/IgM Test Kit(Serum/plasma/whole blood) SCR001398/79 Shigella Antigen Test Kit(Feces) SHI018098/79 Shigella lgG/lgM Test Kit(Serum/plasma/whole blood) SHI017998/79 Syphilis Antibody Test Kit(Serum/plasma/whole blood) SYP005298/79 Typhoid Antigen Test Kit(Feces) TYP008698/79 Typhoid IgG/IgM Test Kit(Serum/plasma/whole blood) TYP008598/79	– 98/79	EUDAMED record Report an error
Virology - RT & POC - other	W0105099099	Chikungunya Test Device(Serum/plasma/whole blood) CHI023698/79 Dengue IgG/IgM/NS1 Test Kit(Serum/plasma/whole blood) DEN003898/79 Dengue Test Device(Serum/plasma/whole blood) DEN023598/79 Monkeypox Virus Antigen Test Kit (Serum/plasma/whole blood/rash exudate) MPV004398/79 SFTSV IgG/IgM Test Kit(Serum/plasma/whole blood) SFT008298/79 2 others Yellow Fever Antigen Test Kit(Serum/plasma/whole blood) YF0013798/79 Zika Test Device (Serum/plasma/whole blood) ZIK023798/79	– 98/79	EUDAMED record Report an error
Parasites - RT & POC - other	W0105090499	Malaria pf/pv Test Kit(Whole blood) MAL004198/79 Malaria Test Device(whole blood) MAL023898/79 Schistosoma Antibody Test Kit(Serum/plasma/whole blood) SEA003598/79	– 98/79	EUDAMED record Report an error
Hepatitis viruses - RT & POC - other	W0105090299	Hepatitis A Test Device(Serum/plasma/whole blood) HEPA24098/79 Hepatitis E Test Device(Serum/plasma/whole blood) HEPE24198/79	– 98/79	EUDAMED record Report an error
Other multiple pathogens - RT & POC	W0105090699	Respiratory Infection Test Device(Nasal/Nasopharyngeal/Oropharyngeal/Serum/plasma/ whole blood) RES024298/79 Vaginitis and Sexually Transmitted Infection Test Device(Urogenital Swab/Serum/plasma/whole blood) VAG024398/79	– 98/79	EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC	W0105090501	COVID 19 Antigen Test Kit (Colloidal Gold Method) SVRAG8998/79	– 98/79	EUDAMED record Report an error

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