Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·SOF-SENSOR

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·ANIMAS VIBE SYSTEM

Mini CGA 540 Style Regulator 0-4lpm Pediatric (0, 1/32, 1/16, 1/8, 1/4, 1/2, 3/4

FDA UDI

SUNSET HEALTHCARE SOLUTIONS, INC.·00848530081027·Mini CGA 540 Style Regulator 0-4lpm Pediatric (...

CGM TELEMEDICINE S.R.L.

Authorized representative

🇮🇹 Italy

Tetraphenyl Borate, Colorimetry, Potassium

FDA classification

FDA Class 2 ·Tetraphenyl Borate, Colorimetry, Potassium

Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

FDA classification

FDA Class 2 ·Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

Terminal Units for Medical Gases, Vacuum and anaesthetic gas scavenging system CGA V-5 (DISS, American Standard)

Basic UDI-DI

EU MDD · Eu Md Class 2b ·G. SAMARAS S.A. MEDICAL GAS SYSTEMS·1 device

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

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

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

FDA Pre-Market Approval

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

Curo L5

FDA UDI

KPI HEALTHCARE, INC.·00850006113064·CURO L5 Glucose Strip

CURO L5 Total Cholesterol Strips

FDA UDI

KPI HEALTHCARE, INC.·00860394001256·Total Cholesterol Strips

CURO L5

FDA UDI

KPI HEALTHCARE, INC.·00860394001225·CURO L5 Cholesterol and Glucose measuring system

AJW Technology Consulting GmbH

Authorized representative

🇩🇪 Germany·18 Manufacturers·23 Devices

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense Continuous Glucose Monitoring System

Continuous Glucose Monitor, Implanted, Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM

PICCOLO 9-CHEM REAGENT ROTOR

FDA registration

ABAXIS, INC.·9 products·🇺🇸 United States

CJ Managementservice

Authorized representative

🇩🇪 Germany

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G5 MOBILE CONTIUOUS GLUCOSE MONITORING SYSTEM

CG MEDICAL

System producer

🇫🇷 France