Manufacturer

Core Technology

ChinaLegal entities : Core Technology Co., Ltd.

First countries of placing on the market declared in EUDAMED : Czechia, Estonia, France, Hungary

EU representative : Medunion S.L. (Spain)

6 categories, 17 models including 17 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Virology - RT & POC - other	W0105099099	(RSV) Respiratory Syncytial Virus Ag Test Strip & Cassette B303-0198/79 COVID-19 Ag Test Cassette98/79 Influenza A/B+COVID-19/RSV+MP Combo Ag Test Cassette98/79 Influenza A/B+RSV/ADV+COVID-19/MP Combo Ag Test Cassette98/79 Influenza A/B+RSV/ADV+MP Combo Ag Test Cassette98/79 2 others Norovirus Ag Test Strip & Cassette B320-2098/79 Rotavirus/Adenovirus/Norovirus Combo Ag Test Cassette ACK21105-C25-00198/79	– 98/79	EUDAMED record Report an error
Bacteriology - RT & POC - other	W0105090199	Group A Streptococcus Ag Test Cassette98/79 Group B Streptococcus Ag test Cassette98/79 MP Ag Test Cassette98/79	– 98/79	EUDAMED record Report an error
Viral antigen/antibody detection - other	W0105040699	(RSV) Respiratory Syncytial Virus IgM Test Strip & Cassette B302-2098/79 COVID-19 IgM/IgG Ab Test Strip & Cassette98/79 Dengue NS1 Ag & IgG/IgM Test Cassette98/79	– 98/79	EUDAMED record Report an error
Parasitology - other	W0105050299	Malaria pf Ag test Cassette98/79 Malaria pf/pv Ag test Cassette98/79	– 98/79	EUDAMED record Report an error
Bacteriology immunoassay - other	W0105011799	Leptospira IgG/IgM Test Cassette B270-2098/79	– 98/79	EUDAMED record Report an error
Hav antibody igm	W0105020104	HAV IgM Test Strip & Cassette B01-1198/79	– 98/79	EUDAMED record Report an error

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