14 results
·
12ms
·
Sources: EU EUDAMED, US FDA
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
SARS-Cov-2＆Influenza A/B Combo Rapid Test Cassette (swab)
Device
EU IVDD
·
Eu Ivd Self Testing
·Hangzhou Realy Tech Co.,Ltd.·On the market
Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab)
Device
EU IVDD
·
Eu Ivd Self Testing
·Hangzhou Realy Tech Co.,Ltd.·On the market
Novel Coronavirus（SARS-Cov-2）Antigen Rapid Test Device（saliva）
Device
EU IVDD
·
Eu Ivd Self Testing
·Hangzhou Realy Tech Co.,Ltd.·On the market
Dynamiker SARS-CoV-2 Ag Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device
Dynamiker SARS-CoV-2 Ag Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device
CeCert/113/W/E.1
Certificate
IVDD Annex III Section 6·Dynamiker Biotechnology (Tianjin) Co., Ltd.·CeCert Sp. z o.o.·2 Basic UDI-DIs
K751416D
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Hangzhou Realy Tech Co.,Ltd.·1 device
K601416D
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Hangzhou Realy Tech Co.,Ltd.·1 device
Novel Coronavirus（SARS-Cov-2）Antigen Rapid Test Device（saliva）
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Hangzhou Realy Tech Co.,Ltd.·1 device
CeCert/100/W/E.1
Certificate
IVDD Annex III Section 6·Hangzhou Realy Tech Co.,Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI
CeCert/025/W/E.1
Certificate
IVDD Annex III Section 6·Hangzhou Realy Tech Co.,Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI
CeCert/036/W/E.1
Certificate
IVDD Annex III Section 6·Hangzhou Realy Tech Co.,Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI