<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06971971810421</udiDi>
    <basicUdiDi>B-06971971810421</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH075040020035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:28:35.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971810414</udiDi>
    <basicUdiDi>B-06971971810414</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH075040018035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:28:34.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971810391</udiDi>
    <basicUdiDi>B-06971971810391</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH075040012035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:28:33.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971810384</udiDi>
    <basicUdiDi>B-06971971810384</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH075040010035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:28:28.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971810377</udiDi>
    <basicUdiDi>B-06971971810377</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH075040008035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:28:28.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971810360</udiDi>
    <basicUdiDi>B-06971971810360</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH075040006035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:28:27.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971810353</udiDi>
    <basicUdiDi>B-06971971810353</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH075040004035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:28:26.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971810346</udiDi>
    <basicUdiDi>B-06971971810346</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH075040003035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:28:22.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971810339</udiDi>
    <basicUdiDi>B-06971971810339</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH075040002035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:28:21.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971810322</udiDi>
    <basicUdiDi>B-06971971810322</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH040040010035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:28:20.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971810315</udiDi>
    <basicUdiDi>B-06971971810315</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH040040008035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:28:20.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971810285</udiDi>
    <basicUdiDi>B-06971971810285</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH040040003035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:28:16.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971810308</udiDi>
    <basicUdiDi>B-06971971810308</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH040040006035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:28:15.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971810292</udiDi>
    <basicUdiDi>B-06971971810292</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH040040004035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:28:14.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971810278</udiDi>
    <basicUdiDi>B-06971971810278</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH040040002035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:27:59.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971810261</udiDi>
    <basicUdiDi>B-06971971810261</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH135030020035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:27:58.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971810247</udiDi>
    <basicUdiDi>B-06971971810247</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH135030015035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:27:56.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971810230</udiDi>
    <basicUdiDi>B-06971971810230</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH135030012035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:27:55.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971810223</udiDi>
    <basicUdiDi>B-06971971810223</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH135030010035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:27:52.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971810216</udiDi>
    <basicUdiDi>B-06971971810216</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH135030008035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:27:51.037Z</lastUpdated>
  </row>
</eudamedExport>