10,000 results
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61ms
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Sources: EU EUDAMED, US FDA
Fluorescence Polarization Immunoassay For Cyclosporine
FDA Pre-Market Approval
FDA Class 2
·TD CYCLOSPORINE AND METABOLITES SERUM ASSAY
PERSONAL TRANSPORT STRETCHER
FDA UDI
FUTURE HEALTH CONCEPTS, INC.·B33771011·FUTURE HEALTH CARE MOBILECARE STRETCHER WITH PN...
Urine BETA CrossLaps® (CTX-I) ELISA
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·Valiant Navion Thoracic Stent Graft System
36594
Certificate
MDD Annex II (excluding section 4)·DxTx Medical, Inc.·GMED SAS·2 Basic UDI-DIs
170726773
Certificate
MDD Annex II (excluding section 4)·Pro-Dex, Inc.·DQS Medizinprodukte GmbH·8 Basic UDI-DIs
059786 MR2 170726773
Certificate
MDD Annex II (excluding section 4)·Pro-Dex, Inc.·DQS Medizinprodukte GmbH·5 Basic UDI-DIs
AT-X ASSESSMENT TOOL (CLINICAL TRIAL ADJUSTABLE ORTHOTIC)
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Turbomed Orthotics inc.·2 devices
Vibrio Cholera (Gene CTX)Real Time PCR Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHANGHAI ZJ BIO-TECH CO., LTD·1 device
Vibrio Cholera CTX Gene/O1/O139 Real Time PCR Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHANGHAI ZJ BIO-TECH CO., LTD·1 device
DTM Natura d.o.o.
Authorized representative
🇸🇮 Slovenia
DEX SURGICAL
System producer
🇫🇷 France
Board, Arm (With Cover), Sterile
FDA classification
FDA Class 1
·Board, Arm (With Cover), Sterile
Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control
FDA classification
FDA Class 2
·Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control
DxTx Medical, Inc.
System producer
🇺🇸 United States
Determine HIV Early Detect
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Abbott Diagnostics Medical Co., Ltd.·1 device
EDTA Capillary Tubes
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Abbott Diagnostics Medical Co., Ltd.·1 device
Determine HIV Controls
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Abbott Diagnostics Medical Co., Ltd.·1 device
Chase Buffer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Abbott Diagnostics Medical Co., Ltd.·1 device
Wire, Guide, Catheter, Exempt
FDA classification
FDA Class 2
·Wire, Guide, Catheter, Exempt