6,887 results · 55ms · Sources: EU EUDAMED, US FDA

Alzheimer’S Disease Pathology Assessment Test

FDA classification
FDA Class 2 ·Alzheimer’S 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