15 results
·
8ms
·
Sources: EU EUDAMED, US FDA
IOLs, APHAKIC, MULTIFOCAL, TORIC, HYDROPHOBIC ACRYLIC
Device
EU MDD
·
Eu Md Class 2b
·AST VisionCare Inc.·On the market·10 countries
PTA BALLOON DILATATION CATHETERS
Device
EU MDD
·
Eu Md Class 2a
·BrosMed Medical Co., Ltd·On the market·1 country
JADE PTA (JADE 18 RX)
Device
EU MDD
·
Eu Md Class 2a
·OrbusNeich Medical (Shenzhen) Co.,Ltd·On the market·1 country
Volpara Health Technologies Limited
Manufacturer
🇳🇿 New Zealand·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V.
Volpara Scorecard
Device
EU MDD
·
Eu Md Class 1
·Volpara Health Technologies Limited·On the market
Asqelio EDOF Toric Preloaded IOL Delivery System
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·AST VisionCare Inc.·1 device
Castor PTA Balloon Dilatation Catheter
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·BrosMed Medical Co., Ltd·1 device
CE 619995
Certificate
MDD Annex II (excluding section 4)·OrbusNeich Medical, B.V.·BSI Group The Netherlands B.V.·181 Basic UDI-DIs
CE 699509
Certificate
MDD Annex II (excluding section 4)·New NI Medical (2011) Ltd.·BSI Group The Netherlands B.V.·1 Basic UDI-DI
Volpara Imaging Software
Basic UDI-DI
EU MDD
·
Eu Md Class 1
·Volpara Health Technologies Limited·1 device
663778
Certificate
MDD Annex II (excluding section 4)·Volpara Health Technologies Limited·BSI Group The Netherlands B.V.·1 Basic UDI-DI
CE697225
Certificate
MDD Annex II (excluding section 4)·ENDRA Life Sciences, Inc.·BSI Group The Netherlands B.V.·1 Basic UDI-DI
CE697659
Certificate
MDD Annex V·Shenzhen AsTec Technology Co., Ltd·BSI Group The Netherlands B.V.·2 Basic UDI-DIs
CE618251
Certificate
MDD Annex II (excluding section 4)·Med-Logics, Inc.·BSI Group The Netherlands B.V.·114 Basic UDI-DIs
CE 685410
Certificate
MDD Annex II (excluding section 4)·Aeon Biotherapeutics Corp.·BSI Group The Netherlands B.V.·6 Basic UDI-DIs