ABX Diluent 10L

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·HORIBA ABX SAS·2 devices

ABX Cleaner 1L

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·HORIBA ABX SAS·3 devices

ABX Basolyse 5L

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·HORIBA ABX SAS·1 device

ABX Pentra Deproteinizer CP

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·HORIBA ABX SAS·1 device

ABX Pentra Dummy-E

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·HORIBA ABX SAS·1 device

ABX Basolyse II 1L

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·HORIBA ABX SAS·1 device

ABX Minidil LMG 10L

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·HORIBA ABX SAS·2 devices

ABX Pentra Etching CP

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·HORIBA ABX SAS·1 device

3MENSIO WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

CAAS II RVA

FDA 510(k)

FDA Class 2 ·Radiology

CAAS II QVA

FDA 510(k)

FDA Class 2 ·Radiology

CAAS INTRAVASCULAR

FDA 510(k)

FDA Class 2 ·Radiology

APPLICATORS FOR AFTERLOADING BRACHYTHERAPY

FDA 510(k)

FDA Class 2 ·Radiology

CAAS QVA 3D, CAAS QCA 3D

FDA 510(k)

FDA Class 2 ·Radiology

CAAS MR FLOW 1.0

FDA 510(k)

FDA Class 2 ·Radiology

CAAS

FDA 510(k)

FDA Class 2 ·Radiology

CAAS MRV

FDA 510(k)

FDA Class 2 ·Radiology

FLEXIPLAN 3D AND 3D+

FDA 510(k)

FDA Class 2 ·Radiology

CAAS A-VALVE

FDA 510(k)

FDA Class 2 ·Radiology

CAAS QCA 3D

FDA 510(k)

FDA Class 2 ·Radiology