BEUDAMED
    10,000 results · 111ms · Sources: EU EUDAMED, US FDA

    TNP/MDR/0011/3870/2023

    Certificate
    MDR QA·Christeyns N.V.·TUV NORD Polska Sp. z o.o

    Iberhospitex, S.A.

    Manufacturer
    🇪🇸 Spain·49 Basic UDI-DIs·54 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., SGS Belgium NV, SGS Belgium NV, SGS Belgium NV, SGS Belgium NV, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    ACCURUN 305 Series 150 HCV RNA Positive Control

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·LGC Clinical Diagnostics, Inc.·1 device

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

    FDA Pre-Market Approval
    FDA Class 3 ·Celsius Fluter, NavistarDS Diagnostic, Celsius DS, EZ Steer Nav DS

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

    FDA Pre-Market Approval
    FDA Class 3 ·NAVISTAR DS CATHETER, EZ Steer Nav DS Bi-Directional Catheter

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·NAVISTAR RMT CATHETER,EZ STEER NAV CATHETER,BIOSENSE WEBSTER CABLES

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·VERSANT HCV RNA 3.0 (BDNA) WITH VERSANT 440 MOLECULAR SYSTEM

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·NAVISTAR/NAVISTAR RMT/EZ STEER NAV/QWIKSTAR CATHETERS/INTERFACE CABLES

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·COBAS® TaqMan® HCV Test, v2.0, for Use with the High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test, v2.0

    DAESUNG MAREF CO.,LTD.

    Manufacturer
    🇰🇷 South Korea·108 Basic UDI-DIs·108 Devices·2 Importers·MTIC InterCert S.r.l. and SGS Belgium NV

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·COBAS TaqMan HCV Test v2.0, For Use With High Pure System

    Catheter, Electrode Recording, Or Probe, Electrode Recording

    FDA Pre-Market Approval
    FDA Class 2 ·NaviStar Catheter, NaviStar RMT Catheter, EZ Steer Nav Catheter, Interface Cables

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·CELSIUS THERMOCOOL, THERMOCOOL SF, NAVISTAR THERMOCOOL, THERMOCOOL SF NAV, THERMOCOOL SMARTTOUCH

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

    FDA Pre-Market Approval
    FDA Class 3 ·NAVISTAR DS/NAVISTAR RMT DS/EZ STEER NAV DS/QWIKSTAR DS

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

    FDA Pre-Market Approval
    FDA Class 3 ·NAVISTAR DS/NAVISTAR RMT DS/EZ STEER NAV DS/QWIKSTAR DS

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·NAVISTAR ,NAVISTAR RMT ,EZ STEER NAV CATHETERS AND,BIOSENSE WEBSTER CABLES

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·EZ STEER THERMOCOOL AND EZ STEER THERMOCOOL NAV DIAGNOSTIC/ABLATION CATHETERS

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·NAVISTAR THERMOCOOL//NAVISTAR RMT//EZ STEER/EZ STEER THERMOCOOL NAV CATHETERS

    HCV Hepatitis C Virus Rapid Test Device (Serum/Plasma)

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·1 device

    System, Laser, Photodynamic Therapy

    FDA Pre-Market Approval
    FDA Class 3 ·VISULAS 690S LASER AND VISULINK PDT ADAPTER