Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·TRIFECTA VALVE

RheOx Generator

Device

EU MDD · Eu Md Class 2b ·Galvanize Therapeutics, Inc.·No longer on the market·5 countries

CENTAURI Connect

Device

EU MDR · Eu Md Class 1 ·Galvanize Therapeutics, Inc.·On the market·9 countries

CENTAURI Generator

Device

EU MDR · Eu Md Class 2b ·Galvanize Therapeutics, Inc.·On the market·9 countries

ECG Trunk Cable

Device

EU MDR · Eu Md Class 1 ·Galvanize Therapeutics, Inc.·On the market·9 countries

Compatibility Cable, BW ThermoCool ST

Device

EU MDR · Eu Md Class 1 ·Galvanize Therapeutics, Inc.·On the market·9 countries

RheOx Catheter

Device

EU MDD · Eu Md Class 2a ·Galvanize Therapeutics, Inc.·No longer on the market·5 countries

RheOx Catheter

Device

EU MDD · Eu Md Class 2a ·Galvanize Therapeutics, Inc.·No longer on the market·5 countries

Lys Medical

System producer

🇧🇪 Belgium

Tourniquet, Gastro-Urology

FDA classification

FDA Class 1 ·Tourniquet, Gastro-Urology

Transducer, Gas Pressure, Differential

FDA classification

FDA Class 1 ·Transducer, Gas Pressure, Differential

Disposable ECMO Set

Basic UDI-DI

EU MDR · Eu Md Class 2a ·CHINABRIDGE (SHENZHEN) MEDICAL TECHNOLOGY CO., LTD.·3 devices

Calcitonin(CLIA)、Calcitonin Calibrators

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

ICON (LR) Limited

Authorized representative

🇮🇪 Ireland·37 Manufacturers·384 Devices

remede eIPG

Basic UDI-DI

EU AIMDD · Eu Aimdd Class ·ZOLL Respicardia, Inc. ·1 device

remede Flexible Programming Wand

Basic UDI-DI

EU AIMDD · Eu Aimdd Class ·ZOLL Respicardia, Inc. ·1 device

Funnel

Basic UDI-DI

EU MDR · Eu Md Class 1 ·SI-BONE, Inc.·1 device

Gauge

Basic UDI-DI

EU MDR · Eu Md Class 1 ·SI-BONE, Inc.·3 devices

Cap

Basic UDI-DI

EU MDR · Eu Md Class 1 ·SI-BONE, Inc.·1 device

Broach stop

Basic UDI-DI

EU MDR · Eu Md Class 1 ·SI-BONE, Inc.·1 device