Substrate HD

Manufacturer

🇫🇷 France·6 Basic UDI-DIs·6 Devices·TÜV Rheinland LGA Products GmbH

VX1

FDA UDI

SUBSTRATE HD·03770019196007·Cardiac Electrophysiology mapping tool

Volta AF-Xplorer

FDA UDI

SUBSTRATE HD·03770019196038·Cardiac Electrophysiology mapping tool

OCTOPUS

Device

EU MDR · Eu Md Class 1 ·Substrate HD·On the market·2 countries

DSUB

Device

EU MDR · Eu Md Class 1 ·Substrate HD·On the market·2 countries

Volta AF-Xplorer II

Device

EU MDR · Eu Md Class 2a ·Substrate HD·On the market·8 countries

Volta AF-Xplorer

Device

EU MDR · Eu Md Class 2a ·Substrate HD·On the market·6 countries

VX1 Hardware

Device

EU MDR · Eu Md Class 1 ·Substrate HD·On the market·4 countries

VX1 Application

Device

EU MDD · Eu Md Class 2a ·Substrate HD·On the market·4 countries

Volta AF-Xplorer II

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Substrate HD·1 device

OCTOPUS

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Substrate HD·1 device

DSUB

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Substrate HD·1 device

Volta AF-Xplorer

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Substrate HD·1 device

VX1 Hardware

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Substrate HD·1 device

VX1 Application

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Substrate HD·1 device

HD 60144656

Certificate

MDD Annex II (excluding section 4)·Substrate HD·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI