10,000 results · 61ms · 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