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<eudamedExport entity="devices">
  <row>
    <udiDi>06957024900455</udiDi>
    <basicUdiDi>695702495001JH</basicUdiDi>
    <tradeName>Non-Vascular Guidewires</tradeName>
    <deviceName>Non-Vascular Guidewires</deviceName>
    <manufacturerName>FORESIGHT TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009708</manufacturerSrn>
    <authorisedRepresentativeName>Creo Medical, S.L.U.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001355</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04010202</emdnCode>
    <emdnDescription>CORONARY ARTERY THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FST-GW-63--A1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:38:15.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>06957024900233</udiDi>
    <basicUdiDi>695702495004JP</basicUdiDi>
    <tradeName>Non-Vascular Guidewires</tradeName>
    <deviceName>Non-Vascular Guidewires</deviceName>
    <manufacturerName>FORESIGHT TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009708</manufacturerSrn>
    <authorisedRepresentativeName>Creo Medical, S.L.U.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001355</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04010202</emdnCode>
    <emdnDescription>CORONARY ARTERY THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FST-GW-88--B1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:38:08.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>06957024900165</udiDi>
    <basicUdiDi>695702495003JM</basicUdiDi>
    <tradeName>Non-Vascular Guidewires</tradeName>
    <deviceName>Non-Vascular Guidewires</deviceName>
    <manufacturerName>FORESIGHT TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009708</manufacturerSrn>
    <authorisedRepresentativeName>Creo Medical, S.L.U.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001355</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04010202</emdnCode>
    <emdnDescription>CORONARY ARTERY THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FST-GW-63--B1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:38:03.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327077156</udiDi>
    <basicUdiDi>4547327BGW007NH</basicUdiDi>
    <tradeName>Grand Slam</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>AG141002</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:53:09.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>04255605600025</udiDi>
    <basicUdiDi>42556056gwcIIIEH</basicUdiDi>
    <tradeName>04255605600025</tradeName>
    <deviceName>Guidewires for Central Circulatory Application</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>41010328</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:28:13.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327085380</udiDi>
    <basicUdiDi>4547327BGW007NH</basicUdiDi>
    <tradeName>MIRACLEbros 3</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>AG14M050</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-25T09:09:21.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327085403</udiDi>
    <basicUdiDi>4547327BGW007NH</basicUdiDi>
    <tradeName>MIRACLEbros 6</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>AG14M060</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-25T09:09:21.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327085410</udiDi>
    <basicUdiDi>4547327BGW007NH</basicUdiDi>
    <tradeName>MIRACLEbros 12</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>AG14M070</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-25T09:09:21.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327085472</udiDi>
    <basicUdiDi>4547327BGW007NH</basicUdiDi>
    <tradeName>MIRACLEbros 3</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>AG14M350</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-25T09:09:21.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327085496</udiDi>
    <basicUdiDi>4547327BGW007NH</basicUdiDi>
    <tradeName>MIRACLEbros 6</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>AG14M360</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-25T09:09:21.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327085502</udiDi>
    <basicUdiDi>4547327BGW007NH</basicUdiDi>
    <tradeName>MIRACLEbros 12</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>AG14M370</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-25T09:09:21.239Z</lastUpdated>
  </row>
  <row>
    <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>
  </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>D-410103285T</udiDi>
    <basicUdiDi>B-410103285T</basicUdiDi>
    <tradeName>D-410103285T</tradeName>
    <deviceName>Guidewire J3-FC-260-035/FS</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04010202</emdnCode>
    <emdnDescription>CORONARY ARTERY THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410102328</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:08:07.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327077194</udiDi>
    <basicUdiDi>4547327BGW007NH</basicUdiDi>
    <tradeName>ASAHI Miracle 12</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>AG14M070</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:28:56.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327077200</udiDi>
    <basicUdiDi>4547327BGW007NH</basicUdiDi>
    <tradeName>ASAHI Miracle 3</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>AG14M050</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:28:56.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327077224</udiDi>
    <basicUdiDi>4547327BGW007NH</basicUdiDi>
    <tradeName>ASAHI Miracle 6</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>AG14M060</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:28:56.127Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327077286</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>AG141302</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:28:56.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327077293</udiDi>
    <basicUdiDi>4547327BGW007NH</basicUdiDi>
    <tradeName>ASAHI Miracle 3</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>AG14M350</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:28:55.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327077316</udiDi>
    <basicUdiDi>4547327BGW007NH</basicUdiDi>
    <tradeName>ASAHI Miracle 6</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>AG14M360</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:28:55.892Z</lastUpdated>
  </row>
</eudamedExport>