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    <tradeName>Sapphire II PRO</tradeName>
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    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-01T00:26:14.782Z</lastUpdated>
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    <tradeName>Sapphire II PRO</tradeName>
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    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>215-203-5U</reference>
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    <lastUpdated>2026-07-01T00:26:05.171Z</lastUpdated>
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    <udiDi>08717853296642</udiDi>
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    <tradeName>Sapphire II PRO</tradeName>
    <deviceName>Sapphire II PRO</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-01T00:26:03.972Z</lastUpdated>
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    <udiDi>08717853296635</udiDi>
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    <tradeName>Sapphire II PRO</tradeName>
    <deviceName>Sapphire II PRO</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>215-123-5U</reference>
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    <lastUpdated>2026-07-01T00:26:02.766Z</lastUpdated>
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    <udiDi>08717853296628</udiDi>
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    <tradeName>Sapphire II PRO</tradeName>
    <deviceName>Sapphire II PRO</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-01T00:25:56.761Z</lastUpdated>
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    <udiDi>08717853296611</udiDi>
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    <tradeName>Sapphire II PRO</tradeName>
    <deviceName>Sapphire II PRO</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
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    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>212-153-5U</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:25:55.593Z</lastUpdated>
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    <udiDi>08717853296604</udiDi>
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    <tradeName>Sapphire II PRO</tradeName>
    <deviceName>Sapphire II PRO</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>212-103-5U</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:25:54.359Z</lastUpdated>
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    <udiDi>08717853296598</udiDi>
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    <tradeName>Sapphire II PRO</tradeName>
    <deviceName>Sapphire II PRO</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
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    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>212-083-5U</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:25:53.161Z</lastUpdated>
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    <udiDi>08717853296581</udiDi>
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    <tradeName>Sapphire II PRO</tradeName>
    <deviceName>Sapphire II PRO</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>212-053-5U</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:25:47.161Z</lastUpdated>
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    <udiDi>08717853296574</udiDi>
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    <tradeName>Sapphire II PRO</tradeName>
    <deviceName>Sapphire II PRO</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>210-153-5U</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:25:45.966Z</lastUpdated>
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    <udiDi>08717853296567</udiDi>
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    <tradeName>Sapphire II PRO</tradeName>
    <deviceName>Sapphire II PRO</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>210-103-5U</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:25:44.757Z</lastUpdated>
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    <udiDi>08717853296550</udiDi>
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    <tradeName>Sapphire II PRO</tradeName>
    <deviceName>Sapphire II PRO</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:25:43.553Z</lastUpdated>
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    <udiDi>08717853296543</udiDi>
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    <tradeName>Sapphire II PRO</tradeName>
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    <lastUpdated>2026-07-01T00:25:37.569Z</lastUpdated>
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    <udiDi>08717853295584</udiDi>
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    <tradeName>Sapphire II NC</tradeName>
    <deviceName>Coronary Dilatation Catheter</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-01T00:25:36.351Z</lastUpdated>
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    <deviceName>Coronary Dilatation Catheter</deviceName>
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    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceName>Coronary Dilatation Catheter</deviceName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <lastUpdated>2026-07-01T00:25:33.954Z</lastUpdated>
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    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
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    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>250-183-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:25:27.951Z</lastUpdated>
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