6,887 results
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55ms
·
Sources: EU EUDAMED, US FDA
AlzheimerS Disease Pathology Assessment Test
FDA classification
FDA Class 2
·AlzheimerS Disease Pathology Assessment Test
Continuous Glucose Monitoring System
Basic UDI-DI
EU MDR
·
Eu Md Class 2b
·SYAI HEALTH TECHNOLOGY PTE. LTD.·4 devices
Automated Visual Acuity Test [AVAT]
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Digital Life Line Pte Ltd·2 devices
Hybrid Microscope
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·X-ZELL Biotech Pte. Ltd.·1 device
Sentosa SA C. diff PCR Test v2.0 (4x24)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SA BRAF V600 PCR Test (4x8)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SA BKV PCR Test (4X48)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SA BKV Quantitation Standards (2x13)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SA BKV Quantitation Controls (4x2)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SA BKV PCR Test (4x24)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SA BKV Controls (8x3)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SA BCR-ABL minor Quantitative RT-PCR Test v2.0 (4x8)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SQ Reporter Software
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SX101
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SQ301 Platform
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Vela Operations Singapore Pte. Ltd.·6 devices
Sentosa SX Whole Blood Kit (4x24)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Vela Operations Singapore Pte. Ltd.·1 device
ViroKey Virus Total Nucleic Acid Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Vela Operations Singapore Pte. Ltd.·2 devices
Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SX Virus Total Nucleic Acid Plus II Kit (4x16)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Vela Operations Singapore Pte. Ltd.·1 device