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<eudamedExport entity="devices">
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    <basicUdiDi>B-06934955949234</basicUdiDi>
    <tradeName>Sapphire NC 24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>222-104-5J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:59:58.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955949241</udiDi>
    <basicUdiDi>B-06934955949241</basicUdiDi>
    <tradeName>Sapphire NC 24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>222-124-5J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:59:58.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955949258</udiDi>
    <basicUdiDi>B-06934955949258</basicUdiDi>
    <tradeName>Sapphire NC 24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>222-154-5J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:59:58.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955949265</udiDi>
    <basicUdiDi>B-06934955949265</basicUdiDi>
    <tradeName>Sapphire NC 24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>222-184-5J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:59:58.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955949272</udiDi>
    <basicUdiDi>B-06934955949272</basicUdiDi>
    <tradeName>Sapphire NC 24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>222-224-5J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:59:58.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955949289</udiDi>
    <basicUdiDi>B-06934955949289</basicUdiDi>
    <tradeName>Sapphire NC 24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>222-264-5J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:59:58.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955949296</udiDi>
    <basicUdiDi>B-06934955949296</basicUdiDi>
    <tradeName>Sapphire NC 24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>225-084-5J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:59:57.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955949302</udiDi>
    <basicUdiDi>B-06934955949302</basicUdiDi>
    <tradeName>Sapphire NC 24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>225-104-5J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:59:57.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955949319</udiDi>
    <basicUdiDi>B-06934955949319</basicUdiDi>
    <tradeName>Sapphire NC 24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>225-124-5J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:59:57.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955949326</udiDi>
    <basicUdiDi>B-06934955949326</basicUdiDi>
    <tradeName>Sapphire NC 24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>225-154-5J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:59:57.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955949333</udiDi>
    <basicUdiDi>B-06934955949333</basicUdiDi>
    <tradeName>Sapphire NC 24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>225-184-5J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:59:57.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955949340</udiDi>
    <basicUdiDi>B-06934955949340</basicUdiDi>
    <tradeName>Sapphire NC 24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>225-224-5J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T23:59:57.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391526210154</udiDi>
    <basicUdiDi>B-05391526210154</basicUdiDi>
    <tradeName>Trapper Exchange Device</tradeName>
    <deviceName>Trapper Exchange Device</deviceName>
    <manufacturerName>Creganna Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000002854</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104010280</emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>H74939330130</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:00:06.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327111829</udiDi>
    <basicUdiDi>B-04547327111829</basicUdiDi>
    <tradeName>ASAHI Corsair Pro Microcatheter, 150cm</tradeName>
    <deviceName>ASAHI Corsair Pro Microcatheter</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>MDD</legislation>
    <emdnCode>C0104010203</emdnCode>
    <emdnDescription>PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRACORONARY AND INTRACARDIAC CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CSR150-26P</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:29:34.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327111812</udiDi>
    <basicUdiDi>B-04547327111812</basicUdiDi>
    <tradeName>ASAHI Corsair Pro Microcatheter, 135cm</tradeName>
    <deviceName>ASAHI Corsair Pro Microcatheter</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>MDD</legislation>
    <emdnCode>C0104010203</emdnCode>
    <emdnDescription>PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRACORONARY AND INTRACARDIAC CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CSR135-26P</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:29:31.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327108799</udiDi>
    <basicUdiDi>B-04547327108799</basicUdiDi>
    <tradeName>ASAHI Caravel Microcatheter,2.6Fr, Straight-Tip, 135cm</tradeName>
    <deviceName>ASAHI Caravel Microcatheter</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>MDD</legislation>
    <emdnCode>C0104010203</emdnCode>
    <emdnDescription>PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRACORONARY AND INTRACARDIAC CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRV135-19P</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:29:30.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327108805</udiDi>
    <basicUdiDi>B-04547327108805</basicUdiDi>
    <tradeName>ASAHI Caravel Microcatheter,2.6Fr, Straight-Tip, 150cm</tradeName>
    <deviceName>ASAHI Caravel Microcatheter</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>MDD</legislation>
    <emdnCode>C0104010203</emdnCode>
    <emdnDescription>PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRACORONARY AND INTRACARDIAC CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRV150-19P</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:29:27.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327105347</udiDi>
    <basicUdiDi>B-04547327105347</basicUdiDi>
    <tradeName>ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Multi Purpose 02, Side Hole</tradeName>
    <deviceName>ASAHI Hyperion Coronary Guide Catheter</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>MDD</legislation>
    <emdnCode>C0104010202</emdnCode>
    <emdnDescription>CARDIAC ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>HW80MP022P10000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:28:06.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327105330</udiDi>
    <basicUdiDi>B-04547327105330</basicUdiDi>
    <tradeName>ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Multi Purpose 02</tradeName>
    <deviceName>ASAHI Hyperion Coronary Guide Catheter</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>MDD</legislation>
    <emdnCode>C0104010202</emdnCode>
    <emdnDescription>CARDIAC ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>HW80MP020P10000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:28:06.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327105323</udiDi>
    <basicUdiDi>B-04547327105323</basicUdiDi>
    <tradeName>ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Multi Purpose 01, Side Hole</tradeName>
    <deviceName>ASAHI Hyperion Coronary Guide Catheter</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>MDD</legislation>
    <emdnCode>C0104010202</emdnCode>
    <emdnDescription>CARDIAC ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>HW80MP012P10000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:28:04.573Z</lastUpdated>
  </row>
</eudamedExport>