16 results
·
14ms
·
Sources: EU EUDAMED, US FDA
uSINE
Device
EU MDR
·
Eu Md Class 2a
·HiCura Medical Pte Ltd·On the market·1 country
uSINE
Device
EU MDR
·
Eu Md Class 2a
·HiCura Medical Pte Ltd·On the market·1 country
PAMS
Device
EU MDR
·
Eu Md Class 1
·HiCura Medical Pte Ltd·On the market·4 countries
OPHTHALMOLOGICAL TREATMENT UNITS
Device
EU MDR
·
Eu Md Class 1
·Digital Life Line Pte Ltd·On the market·4 countries
AVAT
Device
EU MDR
·
Eu Md Class 1
·Digital Life Line Pte Ltd·On the market·4 countries
CARES4WOUNDS C4W-B
Device
EU MDD
·
Eu Md Class 1
·Tetsuyu Healthcare Holdings Pte Ltd·On the market
Position and Angular Marking System (PAMS) Needle Guide
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·HiCura Medical Pte Ltd·1 device
uSINE® (Ultrasound guided spinal landmark identification system)
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·HiCura Medical Pte Ltd·2 devices
Automated Visual Acuity Test [AVAT]
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Digital Life Line Pte Ltd·2 devices
CARES4WOUNDS C4W-B
Basic UDI-DI
EU MDD
·
Eu Md Class 1
·Tetsuyu Healthcare Holdings Pte Ltd·1 device
V1 003496 007
Certificate
IVDD Annex IV (excluding sections 4, 6)·AusDiagnostics Pty Ltd·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
V1 003469 0007
Certificate
IVDD Annex IV (excluding sections 4, 6)·AusDiagnostics Pty Ltd·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
V1 003496 0007
Certificate
IVDD Annex IV (excluding sections 4, 6)·AusDiagnostics Pty Ltd·TÜV SÜD Product Service GmbH·24 Basic UDI-DIs
V1 0034960007
Certificate
IVDD Annex IV (excluding sections 4, 6)·AusDiagnostics Pty Ltd·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
CE 651490
Certificate
MDD Annex II (excluding section 4)·Micropace Pty Ltd·BSI Group The Netherlands B.V.·1 Basic UDI-DI
CE 651409
Certificate
MDD Annex II (excluding section 4)·AtCor Medical Pty Ltd·BSI Group The Netherlands B.V.·3 Basic UDI-DIs