16 results
·
16ms
·
Sources: EU EUDAMED, US FDA
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
PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
Device
EU MDD
·
Eu Md Class 2a
·Hanalytics Pte Ltd·On the market·1 country
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
PAUL® Glaucoma Implant
Device
EU MDD
·
Eu Md Class 2b
·Advanced Ophthalmic Innovations Pte. Ltd.·On the market·12 countries
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
BioMind Diagnostic Support Software
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Hanalytics Pte Ltd·1 device
PeriCoach
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Stratos MedTech Pty Ltd·2 devices
PAUL® Glaucoma Implant
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Advanced Ophthalmic Innovations Pte. Ltd.·1 device
HD601504830001
Certificate
MDD Annex II (excluding section 4)·Hanalytics Pte Ltd·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI
HD-2147677
Certificate
MDD Annex II (excluding section 4)·Advanced Ophthalmic Innovations Pte. Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI