<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06971971816324</udiDi>
    <basicUdiDi>B-06971971816324</basicUdiDi>
    <tradeName>ZENFlex Pro</tradeName>
    <deviceName>Peripheral Drug-eluting Stent System</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>P0704020203</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DRUG ELUTING STENTS (DES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZX05100080A</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:24:34.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971816317</udiDi>
    <basicUdiDi>B-06971971816317</basicUdiDi>
    <tradeName>ZENFlex Pro</tradeName>
    <deviceName>Peripheral Drug-eluting Stent System</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>P0704020203</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DRUG ELUTING STENTS (DES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZX05080080A</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:24:32.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971816300</udiDi>
    <basicUdiDi>B-06971971816300</basicUdiDi>
    <tradeName>ZENFlex Pro</tradeName>
    <deviceName>Peripheral Drug-eluting Stent System</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>P0704020203</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DRUG ELUTING STENTS (DES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZX05060080A</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:24:31.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971816294</udiDi>
    <basicUdiDi>B-06971971816294</basicUdiDi>
    <tradeName>ZENFlex Pro</tradeName>
    <deviceName>Peripheral Drug-eluting Stent System</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>P0704020203</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DRUG ELUTING STENTS (DES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZX05040080A</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:24:30.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971816287</udiDi>
    <basicUdiDi>B-06971971816287</basicUdiDi>
    <tradeName>ZENFlex Pro</tradeName>
    <deviceName>Peripheral Drug-eluting Stent System</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>P0704020203</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DRUG ELUTING STENTS (DES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZX05030080A</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:24:23.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971816270</udiDi>
    <basicUdiDi>B-06971971816270</basicUdiDi>
    <tradeName>ZENFlex Pro</tradeName>
    <deviceName>Peripheral Drug-eluting Stent System</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>P0704020203</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DRUG ELUTING STENTS (DES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZX05020080A</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:24:22.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971814429</udiDi>
    <basicUdiDi>B-06971971814429</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>ZY150035008014A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:24:20.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970596427090</udiDi>
    <basicUdiDi>B-06970596427090</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>ZY075100002035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T03:57:26.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970596427083</udiDi>
    <basicUdiDi>B-06970596427083</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>ZY100090002035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T03:57:25.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970596427076</udiDi>
    <basicUdiDi>B-06970596427076</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>ZY075090002035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T03:57:24.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970596427069</udiDi>
    <basicUdiDi>B-06970596427069</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>ZY130080002035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T03:57:23.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970596427052</udiDi>
    <basicUdiDi>B-06970596427052</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>ZY100080002035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T03:57:17.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970596427045</udiDi>
    <basicUdiDi>B-06970596427045</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>ZY075080002035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T03:57:15.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970596427038</udiDi>
    <basicUdiDi>B-06970596427038</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>ZY130070002035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T03:57:14.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970596426994</udiDi>
    <basicUdiDi>B-06970596426994</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>ZY100070002035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T03:57:13.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970596426987</udiDi>
    <basicUdiDi>B-06970596426987</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>ZY075070002035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T03:57:07.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970596426970</udiDi>
    <basicUdiDi>B-06970596426970</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>ZY130060002035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T03:57:06.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970596426963</udiDi>
    <basicUdiDi>B-06970596426963</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>Drug-coated PTA Balloon Catheter</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T03:57:05.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970596426956</udiDi>
    <basicUdiDi>B-06970596426956</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>ZY075060002035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T03:57:03.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970596426949</udiDi>
    <basicUdiDi>B-06970596426949</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>ZY130050002035A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T03:56:57.824Z</lastUpdated>
  </row>
</eudamedExport>