737 results
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39ms
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Sources: EU EUDAMED, US FDA
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+H
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·PROMOTE/+/RF/Q,PROMOTE ACCEL,PROMOTE QUADRA,UNIFY,UNIFY ASSURA,UNIFY QUADRA,QUADRA ASSURA,EPIC+/HF/HF+/IIHF/II+HF,ATLAS+
Carbapenem Resistant Enterobacteriaceae Test Kit (LFA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device
Dynamiker Cryptococcal Antigen Lateral Flow Assay(LFA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device
Dynamiker Cryptococcal Antigen Lateral Flow Assay(LFA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device
Dynamiker Candida IgG Lateral Flow Assay( LFA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device
Accu-Chek Guide Kit mmol/L FC
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Roche Diabetes Care GmbH·1 device
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·PROMOTE/+/RF/Q, ACCEL/ QUADR;UNIFY ASSURA/ QUADRA, EPIC+/HF/HF+/II HF/II+ HF,ATLAS+HF/II HH/II+ H FAMILY OF CRT-D FAMILY
Magnetic Immunoassay System
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Shenzhen BOSH Diagnostics, Ltd.·1 device
Antigen, Cf, Q Fever
FDA classification
FDA Class 1
·Antigen, Cf, Q Fever
Antiserum, Cf, Q Fever
FDA classification
FDA Class 1
·Antiserum, Cf, Q Fever
VALON TT 577 CSO
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Meridian Medical Oy·1 device
Liver Fibrosis Multi Control
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·4 devices
Lateral Flow (LF) Reader
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Hangzhou Alltest Biotech.Co.,Ltd.·1 device
Lateral Flow (LF) Reader Plus
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Hangzhou Alltest Biotech.Co.,Ltd.·1 device
Lactoferrin (LF) Test Kit (Colloidal Gold)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zhuhai Keyu Biological Engineering Co., Ltd·1 device
Lactoferrin (LF) Test Kit (Colloidal Gold)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zhuhai Keyu Biological Engineering Co., Ltd·1 device
Lactoferrin (LF) Test Kit (Colloidal Gold)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zhuhai Keyu Biological Engineering Co., Ltd·1 device
Lateral Flow (LF) Portable Reader Plus
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Hangzhou Alltest Biotech.Co.,Ltd.·1 device
Lactoferrin (LF) Test Kit (Colloidal Gold)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zhuhai Keyu Biological Engineering Co., Ltd·1 device