Effigerm Wound Care

Basic UDI-DI

EU MDD · Eu Md Class 2a ·CF Pharma Ireland Ltd·1 device

Effigerm Wound Care

Basic UDI-DI

EU MDD · Eu Md Class 2a ·CF Pharma Ireland Ltd·1 device

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval

FDA Class 3 ·FreeStyle Libre 14 Day Flash Glucose Monitoring System

Artis CF

Authorized representative

🇫🇷 France

Assay, Enterovirus Nucleic Acid

FDA classification

FDA Class 2 ·Assay, Enterovirus Nucleic Acid

AJW Technology Consulting GmbH

Authorized representative

🇩🇪 Germany·18 Manufacturers·23 Devices

Curo A1c Analyzer

FDA UDI

KPI HEALTHCARE, INC.·00860394001270·Curo A1c Analyzer

CURO G6s Smart Glucose Meter

FDA UDI

KPI HEALTHCARE, INC.·00860394001249·CURO G6s Smart Glucose Meter

CURO A1c

FDA UDI

KPI HEALTHCARE, INC.·00850006113040·CURO A1c Daily Check Cartridge

CURO Glucose Strips

FDA UDI

KPI HEALTHCARE, INC.·00860394001294·CURO Glucose Strips for G6 and G6s

CURO A1c

FDA UDI

KPI HEALTHCARE, INC.·00850006113033·Curo A1c Test Cartridge

CURO B3

FDA UDI

KPI HEALTHCARE, INC.·00860394001232·CURO B3 Blood Pressure Monitor

CURO A1c

FDA UDI

KPI HEALTHCARE, INC.·00850006113026·CURO A1c Monthly Check Cartridge

CURO G6 Glucose Meter

FDA UDI

KPI HEALTHCARE, INC.·00860394001263·CURO G6 Glucose Meter

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense Continuous Glucose Monitoring System

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

Continuous Glucose Monitor, Implanted, Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM

494-00-00-00

Certificate

MDD Annex V·CF Pharma Ireland Ltd·ITALCERT SRL·1 Basic UDI-DI

494-00-00-DM

Certificate

MDD Annex V·CF Pharma Ireland Ltd·ITALCERT SRL·85 Basic UDI-DIs

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM