<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06974042970932</udiDi>
    <basicUdiDi>B-06974042970932</basicUdiDi>
    <tradeName>ZENFluxion</tradeName>
    <deviceName>Drug-coated PTA Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY075050010035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:47:42.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974042970925</udiDi>
    <basicUdiDi>B-06974042970925</basicUdiDi>
    <tradeName>ZENFluxion</tradeName>
    <deviceName>Drug-coated PTA Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY130040010035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:47:40.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974042970918</udiDi>
    <basicUdiDi>B-06974042970918</basicUdiDi>
    <tradeName>ZENFluxion</tradeName>
    <deviceName>Drug-coated PTA Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY110040010035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:47:34.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974042970901</udiDi>
    <basicUdiDi>B-06974042970901</basicUdiDi>
    <tradeName>ZENFluxion</tradeName>
    <deviceName>Drug-coated PTA Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY100040010035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:47:33.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974042970895</udiDi>
    <basicUdiDi>B-06974042970895</basicUdiDi>
    <tradeName>ZENFluxion</tradeName>
    <deviceName>Drug-coated PTA Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY075040010035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:47:32.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974042970888</udiDi>
    <basicUdiDi>B-06974042970888</basicUdiDi>
    <tradeName>ZENFluxion</tradeName>
    <deviceName>Drug-coated PTA Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY110035010035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:47:31.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974042970871</udiDi>
    <basicUdiDi>B-06974042970871</basicUdiDi>
    <tradeName>ZENFluxion</tradeName>
    <deviceName>Drug-coated PTA Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY075035010035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:47:25.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974042970864</udiDi>
    <basicUdiDi>B-06974042970864</basicUdiDi>
    <tradeName>ZENFluxion</tradeName>
    <deviceName>Drug-coated PTA Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY130030010035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:47:24.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974042970857</udiDi>
    <basicUdiDi>B-06974042970857</basicUdiDi>
    <tradeName>ZENFluxion</tradeName>
    <deviceName>Drug-coated PTA Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY110030010035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:47:22.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974042970840</udiDi>
    <basicUdiDi>B-06974042970840</basicUdiDi>
    <tradeName>ZENFluxion</tradeName>
    <deviceName>Drug-coated PTA Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY100030010035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:47:21.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974042970833</udiDi>
    <basicUdiDi>B-06974042970833</basicUdiDi>
    <tradeName>ZENFluxion</tradeName>
    <deviceName>Drug-coated PTA Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY075030010035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:47:15.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974042970826</udiDi>
    <basicUdiDi>B-06974042970826</basicUdiDi>
    <tradeName>ZENFluxion</tradeName>
    <deviceName>Drug-coated PTA Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY110025010035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:47:14.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974042970819</udiDi>
    <basicUdiDi>B-06974042970819</basicUdiDi>
    <tradeName>ZENFluxion</tradeName>
    <deviceName>Drug-coated PTA Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY110020010035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:47:13.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974042970802</udiDi>
    <basicUdiDi>B-06974042970802</basicUdiDi>
    <tradeName>ZENFluxion</tradeName>
    <deviceName>Drug-coated PTA Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY130060008035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:47:12.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974042970796</udiDi>
    <basicUdiDi>B-06974042970796</basicUdiDi>
    <tradeName>ZENFluxion</tradeName>
    <deviceName>Drug-coated PTA Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY100060008035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:47:06.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974042970789</udiDi>
    <basicUdiDi>B-06974042970789</basicUdiDi>
    <tradeName>ZENFluxion</tradeName>
    <deviceName>Drug-coated PTA Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY075060008035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:47:04.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974042970772</udiDi>
    <basicUdiDi>B-06974042970772</basicUdiDi>
    <tradeName>ZENFluxion</tradeName>
    <deviceName>Drug-coated PTA Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY130050008035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:47:03.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974042970765</udiDi>
    <basicUdiDi>B-06974042970765</basicUdiDi>
    <tradeName>ZENFluxion</tradeName>
    <deviceName>Drug-coated PTA Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY100050008035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:47:02.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974042970758</udiDi>
    <basicUdiDi>B-06974042970758</basicUdiDi>
    <tradeName>ZENFluxion</tradeName>
    <deviceName>Drug-coated PTA Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY075050008035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:46:56.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974042970741</udiDi>
    <basicUdiDi>B-06974042970741</basicUdiDi>
    <tradeName>ZENFluxion</tradeName>
    <deviceName>Drug-coated PTA Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY130040008035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:46:55.360Z</lastUpdated>
  </row>
</eudamedExport>