16 results
·
8ms
·
Sources: EU EUDAMED, US FDA
SpeeDx Pty. Ltd.
Manufacturer
🇦🇺 Australia·1 Basic UDI-DI·3 Devices·1 Importer
Visionflex Pty Limited
Manufacturer
🇦🇺 Australia
Cylite Pty Ltd
Manufacturer
🇦🇺 Australia·1 Basic UDI-DI·2 Devices
Visionsearch Pty Ltd
Manufacturer
🇦🇺 Australia
Stratos MedTech Pty Ltd
Manufacturer
🇦🇺 Australia·1 Basic UDI-DI·2 Devices
BioAnalytics Holdings Pty Ltd
Manufacturer
🇦🇺 Australia
OPTICAL CONSISTENCY TOMOGRAPHS
Device
EU MDR
·
Eu Md Class 2a
·Cylite Pty Ltd·Not intended for eu market
PlexPCR RespiVirus (610)
Device
EU IVDR
·
Eu Ivd Class B
·SpeeDx Pty. Ltd.·On the market·1 country
OPTICAL CONSISTENCY TOMOGRAPHS
Device
EU MDR
·
Eu Md Class 2a
·Cylite Pty Ltd·Not intended for eu market
PlexPCR RespiVirus Positive Control
Device
EU IVDR
·
Eu Ivd Class B
·SpeeDx Pty. Ltd.·On the market·32 countries
PlexPCR RespiVirus (610)
Device
EU IVDR
·
Eu Ivd Class B
·SpeeDx Pty. Ltd.·On the market·7 countries
PeriCoach
Device
EU MDR
·
Eu Md Class 1
·Stratos MedTech Pty Ltd·On the market
PeriCoach
Device
EU MDR
·
Eu Md Class 1
·Stratos MedTech Pty Ltd·On the market
PlexPCR RespiVirus
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·SpeeDx Pty. Ltd.·3 devices
HP-OCT and accessories
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Cylite Pty Ltd·2 devices
PeriCoach
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Stratos MedTech Pty Ltd·2 devices