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    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006441</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCB-37512</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:40:30.454Z</lastUpdated>
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    <deviceName>RISE NC</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <manufacturerName>Biosensors Europe SA</manufacturerName>
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    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:40:22.051Z</lastUpdated>
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    <deviceName>RISE NC</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
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    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCB-35020</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:40:21.080Z</lastUpdated>
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    <deviceName>RISE NC</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
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    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCB-35015</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:40:18.444Z</lastUpdated>
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    <deviceName>RISE NC</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
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    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCB-35012</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:40:14.844Z</lastUpdated>
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    <deviceName>RISE NC</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCB-35010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:40:12.445Z</lastUpdated>
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    <deviceName>RISE NC</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCB-35008</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:40:11.237Z</lastUpdated>
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    <tradeName>08888893024967</tradeName>
    <deviceName>RISE NC</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006441</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCB-32525</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:40:08.836Z</lastUpdated>
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    <deviceName>RISE NC</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
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    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCB-32520</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:40:05.238Z</lastUpdated>
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    <deviceName>RISE NC</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCB-32515</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:40:02.838Z</lastUpdated>
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    <deviceName>RISE NC</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCB-32512</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:40:01.638Z</lastUpdated>
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    <deviceName>RISE NC</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCB-32510</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:39:59.235Z</lastUpdated>
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    <deviceName>RISE NC</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
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    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCB-32508</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:39:55.663Z</lastUpdated>
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    <deviceName>RISE NC</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <manufacturerName>Biosensors Europe SA</manufacturerName>
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    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
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    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <deviceName>RISE NC</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
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    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
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