Manufacturer

Jiangsu Medomics Medical Technology

ChinaLegal entities : Jiangsu Medomics Medical Technology Co.,Ltd.

Markets : Czechia · Finland · Germany · Italy · Lithuania · Netherlands · Northern Ireland · Poland · Portugal · Spain · United States

Approvals : EU – class C · United States (FDA) – · class I

EU representative : Mega Eurostar Sp. z o.o. (Poland)

3 categories, 12 models including 12 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Virology - RT & POC - other	W0105099099	Co-Test 5in1 COMBO TEST SARS-CoV-2/Influensa A/B ADV/RSV Antigen 123143-01-102 123143-02-102 123143-05-102 123143-20-1023 refs Eight Respiratory Pathogen Antigen Rapid Test Kit (LFIA) 123145-01-102 123145-02-102 123145-05-102 123145-20-1023 refs I&A Medical SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit(LFIA) 1041-14-0198/79 I&A medical SARS-CoV-2 Antigen Test Kit (LFIA)98/79 I&A medical SARS-CoV-2/RSV+Influenza A/B Antigen Test Kit (LFIA)98/79 4 others SARS-CoV-2 Antigen Test Kit (LFIA)98/79 SARS-CoV-2 AntigenTest kit (LFIA)2 refs98/79 SARS-CoV-2/ RSV+Influenza A/B Antigen Test Kit (LFIA)98/79 SARS-CoV-2/FluA/FluB+ADV/RSV/SA Antigen Combo Rapid Test Kit (LFIA)2 refs98/79	C IVDR, 98/79	EUDAMED record Report an error
Other multiple pathogens - RT & POC	W0105090699	Candida albicans/ Trichomonas vaginalis/ Gardnerella vaginalis antigen Combo Test Kit (LFIA)98/79 Candida albicans/ Trichomonas vaginalis/ Gardnerella vaginalis antigen Combo Test Kit (LFIA) 012113-01-02；012113-02-02 ；012113-05-02；012113-20-023 refs	C IVDR, 98/79	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	Group A streptococcus Rapid test Kit98/79	– 98/79	EUDAMED record Report an error

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