17 results
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8ms
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Sources: EU EUDAMED, US FDA
Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer
🇨🇳 China·5 Basic UDI-DIs·5 Devices·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH
Merlin Biomedical (Xiamen) Co., Ltd.
Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device·CeCert Sp. z o.o.
fPSA Rapid Test
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·On the market
PSA Rapid Test
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·On the market
CancerCheck® PSA
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·On the market
CancerCheck ® fPSA
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·On the market
Colloidal Gold Reader
Device
EU IVDR
·
Eu Ivd Class A
·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·Not intended for eu market
SARS-CoV-2 Antigen Rapid Test Cassette
Device
EU IVDD
·
Eu Ivd Self Testing
·Merlin Biomedical (Xiamen) Co., Ltd.·On the market
fPSA Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device
PSA Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device
PSA Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device
fPSA Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device
Colloidal Gold Reader
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device
SARS-CoV-2 Antigen Rapid Test Cassette
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Merlin Biomedical (Xiamen) Co., Ltd.·1 device
CeCert/037/W/E.1
Certificate
IVDD Annex III Section 6·Merlin Biomedical (Xiamen) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI
V1 061788 0008
Certificate
IVDD Annex IV (excluding sections 4, 6)·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs
No. V1 061788 0008
Certificate
IVDD Annex IV (excluding sections 4, 6)·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs