80 results
·
8ms
·
Sources: EU EUDAMED, US FDA
Biolab Zrt
Manufacturer
🇭🇺 Hungary·23 Basic UDI-DIs·306 Devices·NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC)
Hangzhou Fanttest Biotech Co., Ltd.
Manufacturer
🇨🇳 China·2 Basic UDI-DIs·2 Devices·1 Importer·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Anbio (Xiamen) Biotechnology Co.,Ltd.
Manufacturer
🇨🇳 China·32 Basic UDI-DIs·35 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer
🇨🇳 China·192 Basic UDI-DIs·192 Devices·1 Importer·CeCert Sp. z o.o.
COVID-19 (SARS-CoV-2) Antigen Test Kit
Device
EU IVDD
·
Eu Ivd Self Testing
·Hangzhou Fanttest Biotech Co., Ltd.·On the market
COVID-19 (SARS-CoV-2) Antigen Test Kit
Device
EU IVDD
·
Eu Ivd Self Testing
·Hangzhou Fanttest Biotech Co., Ltd.·On the market
Hangzhou Realy Tech Co.,Ltd.
Manufacturer
🇨🇳 China·128 Basic UDI-DIs·129 Devices·CeCert Sp. z o.o., CeCert Sp. z o.o., and CeCert Sp. z o.o.
BOIRON
Device
EU IVDD
·
Eu Ivd Self Testing
·Anbio (Xiamen) Biotechnology Co.,Ltd.·On the market·31 countries
BOIRON
Device
EU IVDD
·
Eu Ivd Self Testing
·Anbio (Xiamen) Biotechnology Co.,Ltd.·On the market·31 countries
Anbio Biotech
Device
EU IVDD
·
Eu Ivd Self Testing
·Anbio (Xiamen) Biotechnology Co.,Ltd.·On the market·31 countries
Anbio Biotech
Device
EU IVDD
·
Eu Ivd Self Testing
·Anbio (Xiamen) Biotechnology Co.,Ltd.·On the market·31 countries
BOIRON
Device
EU IVDD
·
Eu Ivd Self Testing
·Anbio (Xiamen) Biotechnology Co.,Ltd.·On the market·31 countries
CORONAVIRUS [obsolete from 2025-01-01]
Device
EU IVDD
·
Eu Ivd Self Testing
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·On the market
CORONAVIRUS [obsolete from 2025-01-01]
Device
EU IVDD
·
Eu Ivd Self Testing
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·On the market
COVID-19 (SARS-CoV-2) Antigen Test Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Hangzhou Fanttest Biotech Co., Ltd.·1 device
COVID-19 (SARS-CoV-2) Antigen Test kit
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Hangzhou Fanttest Biotech Co., Ltd.·1 device
HU/CA01/54096/13
Certificate
IVDD Annex III Section 6·Biolab Zrt·NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC)·1 Basic UDI-DI
1434-IVDD-263/2022
Certificate
IVDD Annex III Section 6·Hangzhou Fanttest Biotech Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs
XLD Agar, PH EUR - USP (500 g)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Biolab Zrt·On the market·32 countries
BOIRON TEST&CARE COVID-19 AUTOTEST NASAL
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Anbio (Xiamen) Biotechnology Co.,Ltd.·1 device