47 results
·
68ms
·
Sources: EU EUDAMED, US FDA
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Makoto Intravascular Imaging System™
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Infraredx, Inc.·1 device
Dualpro™ IVUS+NIRS Imaging Catheter
Basic UDI-DI
EU MDD
·
Eu Md Class 3
·Infraredx, Inc.·1 device
670602
Certificate
MDD Annex II (excluding section 4)·Infraredx, Inc.·BSI Group The Netherlands B.V.·1 Basic UDI-DI
670605
Certificate
MDD Annex II Section 4·Infraredx, Inc.·BSI Group The Netherlands B.V.·1 Basic UDI-DI
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
MedEnvoy Global BV
Importer
🇳🇱 Netherlands·234 Manufacturers