20 results
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8ms
·
Sources: EU EUDAMED, US FDA
Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer
🇨🇳 China·212 Basic UDI-DIs·212 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., TÜV Rheinland LGA Products GmbH, 3EC International a.s., TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and TÜV Rheinland LGA Products GmbH
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.
CLIN. CHEM. RT & POC - OTHER
Device
EU IVDD
·
Eu Ivd Self Testing
·Assure Tech. (Hangzhou) Co., Ltd.·On the market·1 country
COVID-19 & Influenza A/B Antigen Nasal Test Kit
Device
EU IVDD
·
Eu Ivd Self Testing
·Assure Tech. (Hangzhou) Co., Ltd.·On the market·1 country
COVID-19 Antigen Nasal Test Kit
Device
EU IVDD
·
Eu Ivd Self Testing
·Assure Tech. (Hangzhou) Co., Ltd.·On the market·1 country
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
2020-IVD/DE-006/A
Certificate
IVDD Annex III Section 6·Assure Tech. (Hangzhou) Co., Ltd.·3EC International a.s.·1 Basic UDI-DI
CeCert/081/W/E.4
Certificate
IVDD Annex III Section 6·Assure Tech. (Hangzhou) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI
1434-IVDD-078/2022
Certificate
IVDD Annex III Section 6·Assure Tech. (Hangzhou) Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI
Vaginal pH Test Device
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Assure Tech. (Hangzhou) Co., Ltd.·1 device
COVID-19 Antigen Nasal Test Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Assure Tech. (Hangzhou) Co., Ltd.·1 device
COVID-19 & Influenza A/B Antigen Nasal Test Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Assure Tech. (Hangzhou) 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
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