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    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
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    <tradeName>Bioptimal Thermodilution Catheter and Kits</tradeName>
    <deviceName>Thermodilution Catherter and Kits</deviceName>
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    <tradeName>Bioptimal Thermodilution Catheter and Kits</tradeName>
    <deviceName>Thermodilution Catherter and Kits</deviceName>
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    <tradeName>Bioptimal Central Venous Catheter and Catherization Kit</tradeName>
    <deviceName>Central Venous Catheter and Catherization Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <basicUdiDi>B-08886483509986</basicUdiDi>
    <tradeName>Bioptimal Central Venous Catheter and Catheterization Kit</tradeName>
    <deviceName>Central Venous Catheter and Catheterization Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Bioptimal Central Venous Catheter and Catherization Kit</tradeName>
    <deviceName>Central Venous Catheter and Catherization Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <tradeName>Bioptimal Central Venous Catheter and Catherization Kit</tradeName>
    <deviceName>Central Venous Catheter and Catherization Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
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    <tradeName>Bioptimal Thermodilution Catheter and Kits</tradeName>
    <deviceName>Thermodilution Catherter and Kits</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>THERMODILUTION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:46:02.661Z</lastUpdated>
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    <tradeName>Bioptimal Bipolar Pacing Catheter</tradeName>
    <deviceName>Bioptimal Bipolar Pacing Catheter</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020201</emdnCode>
    <emdnDescription>TEMPORARY ENDOCARDIAL LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP-0002-020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:46:00.949Z</lastUpdated>
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    <tradeName>Bioptimal Vascular Introducer Kit</tradeName>
    <deviceName>Vascular Introducer Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
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    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:46:00.154Z</lastUpdated>
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    <tradeName>Bioptimal Central Venous Catheter and Catherization Kit</tradeName>
    <deviceName>Central Venous Catheter and Catherization Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <placedOnMarketCountry>Greece</placedOnMarketCountry>
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    <tradeName>Bioptimal Central Venous Catheter and Catheterization Kit</tradeName>
    <deviceName>Central Venous Catheter and Catheterization Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
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    <tradeName>Bioptimal Thermodilution Catheter and Kits</tradeName>
    <deviceName>Thermodilution Catherter and Kits</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
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    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <tradeName>Bioptimal Bipolar Pacing Catheter</tradeName>
    <deviceName>Bipolar Pacing Catheter</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
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    <tradeName>Bioptimal Thermodilution Catheter and Kits</tradeName>
    <deviceName>Thermodilution Catherter and Kits</deviceName>
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    <tradeName>Bioptimal Thermodilution Catheter and Kits</tradeName>
    <deviceName>Thermodilution Catherter and Kits</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
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    <tradeName>Bioptimal Bipolar Pacing Catheter</tradeName>
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    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
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    <tradeName>Bioptimal Vascular Introducer Kit</tradeName>
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    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
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    <tradeName>Bioptimal Thermodilution Catheter and Kits</tradeName>
    <deviceName>Thermodilution Catherter and Kits</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
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    <tradeName>Bioptimal Thermodilution Catheter and Kits</tradeName>
    <deviceName>Thermodilution Catherter and Kits</deviceName>
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