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<eudamedExport entity="devices">
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    <udiDi>04547327133050</udiDi>
    <basicUdiDi>4547327BGW011N8</basicUdiDi>
    <tradeName>SION blue ES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ASAHI INTECC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010199</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04010201</emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AHW14R017P</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-25T09:08:25.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327133067</udiDi>
    <basicUdiDi>4547327BGW011N8</basicUdiDi>
    <tradeName>SION blue ES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ASAHI INTECC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010199</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04010201</emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AHW14R317P</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-25T09:08:25.634Z</lastUpdated>
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    <udiDi>04547327077637</udiDi>
    <basicUdiDi>4547327BGW007NH</basicUdiDi>
    <tradeName>Grand Slam</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ASAHI INTECC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010199</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C04010202</emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG141302J</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-24T00:38:05.065Z</lastUpdated>
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    <udiDi>04547327149617</udiDi>
    <basicUdiDi>4547327BGW008NK</basicUdiDi>
    <tradeName>ASAHI Conquest Pro</tradeName>
    <deviceName>ASAHI Conquest Pro PCI Guide Wire, Confianza Pro PCI Guide Wire, ASAHI Conquest Pro 12 PCI Guide Wire, Confianza Pro 12 PCI Guide Wire</deviceName>
    <manufacturerName>ASAHI INTECC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010199</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04010201</emdnCode>
    <emdnDescription>CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGH143190</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:25:41.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327144797</udiDi>
    <basicUdiDi>4547327AGW017N7</basicUdiDi>
    <tradeName>Fielder XT-A</tradeName>
    <deviceName>PCI Guide Wire Fielder XT-A, PCI Guide Wire Fielder XT-R</deviceName>
    <manufacturerName>ASAHI INTECC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010199</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04010201</emdnCode>
    <emdnDescription>CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APW14R009P</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:25:40.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327144247</udiDi>
    <basicUdiDi>4547327BGW011N8</basicUdiDi>
    <tradeName>SION</tradeName>
    <deviceName>PCI Guide Wire SION PCI Guide Wire SION blue PCI Guide Wire SION black PCI Guide Wire SION blue ES PCI Guide Wire SUOH 03</deviceName>
    <manufacturerName>ASAHI INTECC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010199</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04010201</emdnCode>
    <emdnDescription>CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AHW14R201S</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:25:37.902Z</lastUpdated>
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  <row>
    <udiDi>04547327141185</udiDi>
    <basicUdiDi>4547327DGW002NZ</basicUdiDi>
    <tradeName>Fielder</tradeName>
    <deviceName>PCI Guide Wire</deviceName>
    <manufacturerName>ASAHI INTECC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010199</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04010201</emdnCode>
    <emdnDescription>CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGP140200</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:25:35.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327141178</udiDi>
    <basicUdiDi>4547327DGW004P5</basicUdiDi>
    <tradeName>ULTIMATEbros 3</tradeName>
    <deviceName>PCI Guide Wire Rinato / PCI Guide Wire PROWATER, PCI Guide Wire Route / PCI Guide Wire PROWATERflex,　PCI Guide Wire ULTIMATEbros 3</deviceName>
    <manufacturerName>ASAHI INTECC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010199</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04010201</emdnCode>
    <emdnDescription>CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AHW14S203S</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:25:34.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327141086</udiDi>
    <basicUdiDi>4547327BGW007NH</basicUdiDi>
    <tradeName>ASAHI Miracle 3</tradeName>
    <deviceName>Grand Slam PCI Guide Wire, ASAHI Miracle 3  PCI Guide Wire, MIRACLEbros 3 PCI Guide Wire, ASAHI Miracle 6 PCI Guide Wire, MIRACLEbros 6 PCI Guide Wire, ASAHI Miracle 12 PCI Guide Wire, MIRACLEbros 12 PCI Guide Wire</deviceName>
    <manufacturerName>ASAHI INTECC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010199</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04010202</emdnCode>
    <emdnDescription>CORONARY ARTERY THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG14M250</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:25:33.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327139830</udiDi>
    <basicUdiDi>4547327DGW003P3</basicUdiDi>
    <tradeName>ASAHI Miracle Neo 3</tradeName>
    <deviceName>ASAHI Miracle Neo 3 PCI Guide Wire</deviceName>
    <manufacturerName>ASAHI INTECC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010199</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04010201</emdnCode>
    <emdnDescription>CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH14R012P</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:25:30.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327116824</udiDi>
    <basicUdiDi>4547327DGW001NX</basicUdiDi>
    <tradeName>ASAHI Gaia Next 1</tradeName>
    <deviceName>ASAHI Gaia Next</deviceName>
    <manufacturerName>ASAHI INTECC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010199</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04010201</emdnCode>
    <emdnDescription>CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH14R019P</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:25:29.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729887775</udiDi>
    <basicUdiDi>01915060000000000000438ND</basicUdiDi>
    <tradeName>Stretch™</tradeName>
    <deviceName>Stretch</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04010201</emdnCode>
    <emdnDescription>CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H7493930800</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:09:31.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729837480</udiDi>
    <basicUdiDi>01915060000000000000195NA</basicUdiDi>
    <tradeName>Stingray™</tradeName>
    <deviceName>Stingray Extension Wire</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04010299</emdnCode>
    <emdnDescription>CORONARY ARTERY THERAPEUTIC GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H749M3010B0</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:58:16.670Z</lastUpdated>
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  <row>
    <udiDi>D-GuidewireV2</udiDi>
    <basicUdiDi>B-GuidewireV2</basicUdiDi>
    <tradeName>D-GuidewireV2</tradeName>
    <deviceName>Guidewire</deviceName>
    <manufacturerName>Shanghai INT Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009966</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04010102</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0.014''</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:44:17.512Z</lastUpdated>
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  <row>
    <udiDi>D-8682408633268AG</udiDi>
    <basicUdiDi>B-8682408633268AG</basicUdiDi>
    <tradeName>Inwire</tradeName>
    <deviceName>Inwire  Guidewire, Angioplasty, 018" 260 cm</deviceName>
    <manufacturerName>İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000019963</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATA0098</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T13:22:19.975Z</lastUpdated>
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  <row>
    <udiDi>D-86824086332519X</udiDi>
    <basicUdiDi>B-86824086332519X</basicUdiDi>
    <tradeName>Inwire</tradeName>
    <deviceName>Inwire Guidewire, Angioplasty, 014" 150 cm</deviceName>
    <manufacturerName>İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000019963</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATA0095</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T13:22:19.717Z</lastUpdated>
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  <row>
    <udiDi>D-8682408633244A2</udiDi>
    <basicUdiDi>B-8682408633244A2</basicUdiDi>
    <tradeName>Inwire</tradeName>
    <deviceName>Inwire Guidewire, Angioplasty , 014" 260 cm</deviceName>
    <manufacturerName>İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000019963</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATA0096</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T13:22:16.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8682408633237A5</udiDi>
    <basicUdiDi>B-8682408633237A5</basicUdiDi>
    <tradeName>Inwire</tradeName>
    <deviceName>Inwire  Guidewire, Angioplasty, 018" 150 cm</deviceName>
    <manufacturerName>İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000019963</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATA0097</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T13:22:14.375Z</lastUpdated>
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  <row>
    <udiDi>D-86824086310118T</udiDi>
    <basicUdiDi>B-86824086310118T</basicUdiDi>
    <tradeName>GuideX</tradeName>
    <deviceName>GuideX  Guidewire, Angioplasty, 035" 150 cm</deviceName>
    <manufacturerName>İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000019963</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATA0099</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T13:18:49.251Z</lastUpdated>
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  <row>
    <udiDi>D-86814100609013X</udiDi>
    <basicUdiDi>B-86814100609013X</basicUdiDi>
    <tradeName>Inwire</tradeName>
    <deviceName>Inwire Guidewire / 0,038" / Hydrophilic / RO Tip/ 150 cm</deviceName>
    <manufacturerName>İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000019963</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA0090</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T12:26:08.819Z</lastUpdated>
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</eudamedExport>