199 results
·
178ms
·
Sources: EU EUDAMED, US FDA
Sentosa SA CMV Controls Set (8x3)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SA CHIKV RT-PCR Test (4x8)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SA BCR-ABL Major Quantitative RT-PCR Test v2.0 (4x8)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SQ Thyroid Cancer Panel (4x8)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SQ Melanoma Panel (4x8)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SQ NSCLC Panel (4x8)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SQ HIV Genotyping Assay (4x16)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SQ HCV Genotyping Assay (4x16)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SQ CRC Panel (4x8)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
RapidKey COVID-19 Antigen Self Test (25)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
RapidKey COVID-19 Antigen Self Test (7)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
RapidKey COVID-19 Antigen Self Test (5)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
RapidKey COVID-19 Antigen Self Test (2)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
RapidKey COVID-19 Antigen Self Test (1)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
Vela Diagnostics Germany GmbH
Authorized representative
🇩🇪 Germany·1 Manufacturer·82 Devices
HL 20744998-1
Certificate
IVDD Annex IV (excluding sections 4, 6)·Vela Operations Singapore Pte. Ltd.·TÜV Rheinland LGA Products GmbH·3 Basic UDI-DIs
HL 2074998-1
Certificate
IVDD Annex IV (excluding sections 4, 6)·Vela Operations Singapore Pte. Ltd.·TÜV Rheinland LGA Products GmbH·7 Basic UDI-DIs
IL 2074998-2
Certificate
IVDD Annex IV Section 4·Vela Operations Singapore Pte. Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI
IL 2074998-1
Certificate
IVDD Annex IV Section 4·Vela Operations Singapore Pte. Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI