Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE GENERATOR AND PROGRAMMER SOFTWARE MODEL 3307, V2.2A

DD Prefab DFX 38 Set

Basic UDI-DI

EU MDD · Eu Md Class 2b ·Dental Direkt GmbH·1 device

DD Prefab DFX 55 Set

Basic UDI-DI

EU MDD · Eu Md Class 2b ·Dental Direkt GmbH·1 device

DD Prefab DFX 45 Set

Basic UDI-DI

EU MDD · Eu Md Class 2b ·Dental Direkt GmbH·1 device

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM;GFX OVER-THE-WIRE CORONARY STENT SYSTEM

Disc-FX® Guidewire

FDA UDI

ELLIQUENCE, LLC·00846338010911·

Disc-FX® Guidewire

FDA UDI

ELLIQUENCE, LLC·00846338001476·

Disc-FX® Guidewire

FDA UDI

ELLIQUENCE, LLC·00846338001483·

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·AVE MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM AND AVE GFX OVER-THE-WIRE CORONARY STENT SYSTEM

Quantum Outback

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Pride Mobility Products Corporation·1 device

RFX+Care International A/S

Authorized representative

🇩🇰 Denmark·2 Manufacturers·646 Devices

Medical Trolley

Basic UDI-DI

EU MDR · Eu Md Class 1 ·JIANGSU YONGXIN MEDICAL EQUIPMENT CO., LTD·1 device

Wound Skin Closure Strip

Basic UDI-DI

EU MDR · Eu Md Class 1 ·RFX+CARE Manufacturing Co., Ltd.·1 device

Forclaz FAK900

Basic UDI-DI

EU MDD · Eu Md Class 1 ·RFX+CARE Manufacturing Co., Ltd.·1 device

Refill FAK

Basic UDI-DI

EU MDD · Eu Md Class 1 ·RFX+CARE Manufacturing Co., Ltd.·1 device

Forclaz FAK 100

Basic UDI-DI

EU MDD · Eu Md Class 1 ·RFX+CARE Manufacturing Co., Ltd.·1 device

Forclaz FAK

Basic UDI-DI

EU MDD · Eu Md Class 1 ·RFX+CARE Manufacturing Co., Ltd.·1 device

Cold /Hot pack

Basic UDI-DI

EU MDR · Eu Md Class 1 ·RFX+CARE Manufacturing Co., Ltd.·2 devices

MA TROUSSEDE SECOURS

Basic UDI-DI

EU MDD · Eu Md Class 2a ·RFX+CARE Manufacturing Co., Ltd.·1 device

Nose strips

Basic UDI-DI

EU MDR · Eu Md Class 1 ·RFX+CARE Manufacturing Co., Ltd.·1 device