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