5 results
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17ms
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Sources: EU EUDAMED, US FDA
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Country: Taiwan
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VitaPCR SARS-CoV-2 Gen 2 Assay
Device
EU IVDD
·
Eu Ivd General
·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·On the market
Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)
FDA 510(k)
FDA Class 2
·Cardiovascular
Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
FDA 510(k)
FDA Class 2
·Cardiovascular
VitaPCR SARS-CoV-2 Gen 2 External Control Set
Device
EU IVDD
·
Eu Ivd General
·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·On the market
VitaPCR SARS-CoV-2 Gen 2 Assay
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·1 device