6,141 results · 40ms · Sources: EU EUDAMED, US FDA

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Paradigm Real-Time REVEL System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MINIMED 630G SYSTEM WITH SMARTGUARD

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 630G System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 530G System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Guardian Connect system

Chromogranin A

FDA classification
FDA Class 2 ·Chromogranin A

CR-03-1156-859-24

Certificate
MDR QMS·CGI Suomi Oy·Eurofins Electric & Electronics Finland Oy

C-01-1156-735-20

Certificate
MDD Annex II (excluding section 4)·CGI Suomi Oy·Eurofins Electric & Electronics Finland Oy·2 Basic UDI-DIs

Cancer Antigen 15-3(CLIA)、CA15-3 Calibrators

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

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 670G System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·Artificial Pancreas Device System Threshold Suspend

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Paradigm Real-Time Reveal System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 630G System With SmartGuard

MARIE PACS

Basic UDI-DI
EU MDR · Eu Md Class 2b ·OR-CZ spol. s r.o.·1 device

MARIE PACS

Basic UDI-DI
EU MDD · Eu Md Class 2b ·OR-CZ spol. s r.o.·1 device

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC MINIMED CONTINUOUS 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

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 670G System