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    <basicUdiDi>B-06936841202010</basicUdiDi>
    <tradeName>06936841202010</tradeName>
    <deviceName>Balloon inflation devices</deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104010280</emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>104006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:16:06.280Z</lastUpdated>
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    <udiDi>06936841201976</udiDi>
    <basicUdiDi>B-06936841201976</basicUdiDi>
    <tradeName>06936841201976</tradeName>
    <deviceName>Balloon inflation devices</deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104010280</emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>103003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:15:50.011Z</lastUpdated>
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    <udiDi>06936841201037</udiDi>
    <basicUdiDi>B-06936841201037</basicUdiDi>
    <tradeName>06936841201037</tradeName>
    <deviceName>Balloon inflation devices</deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104010280</emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>104004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:15:44.870Z</lastUpdated>
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    <udiDi>06936841200207</udiDi>
    <basicUdiDi>B-06936841200207</basicUdiDi>
    <tradeName>06936841200207</tradeName>
    <deviceName>Balloon inflation devices</deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104010280</emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>104003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:15:22.800Z</lastUpdated>
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    <udiDi>06934955921018</udiDi>
    <basicUdiDi>B-06934955921018</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-1005J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:44.305Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955921025</udiDi>
    <basicUdiDi>B-06934955921025</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-1008J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:44.270Z</lastUpdated>
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    <udiDi>06934955921032</udiDi>
    <basicUdiDi>B-06934955921032</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-1010J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:44.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955921049</udiDi>
    <basicUdiDi>B-06934955921049</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-1015J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:44.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955921056</udiDi>
    <basicUdiDi>B-06934955921056</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-1205J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:44.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955921063</udiDi>
    <basicUdiDi>B-06934955921063</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-1208J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:44.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955921070</udiDi>
    <basicUdiDi>B-06934955921070</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-1210J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:44.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955921087</udiDi>
    <basicUdiDi>B-06934955921087</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-1215J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:44.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955921094</udiDi>
    <basicUdiDi>B-06934955921094</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-1510J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:44.113Z</lastUpdated>
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  <row>
    <udiDi>06934955921100</udiDi>
    <basicUdiDi>B-06934955921100</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-1512J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:44.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955921117</udiDi>
    <basicUdiDi>B-06934955921117</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-1515J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:44.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955921124</udiDi>
    <basicUdiDi>B-06934955921124</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-1520J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:44.052Z</lastUpdated>
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    <udiDi>06934955921131</udiDi>
    <basicUdiDi>B-06934955921131</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-1710J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:44.027Z</lastUpdated>
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    <udiDi>06934955921155</udiDi>
    <basicUdiDi>B-06934955921155</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-1720J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:44.012Z</lastUpdated>
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    <udiDi>06934955921162</udiDi>
    <basicUdiDi>B-06934955921162</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-2010J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:43.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955921179</udiDi>
    <basicUdiDi>B-06934955921179</basicUdiDi>
    <tradeName>Sapphire II (RX)</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>234-R-2012J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:28:43.979Z</lastUpdated>
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