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    <tradeName>06936595751253</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1201Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:56:23.476Z</lastUpdated>
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    <udiDi>06925912718468</udiDi>
    <basicUdiDi>692591270025GZ</basicUdiDi>
    <tradeName>iFlash-CA 15-3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:12:58.660Z</lastUpdated>
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    <udiDi>06933260207367</udiDi>
    <basicUdiDi>B-06933260207367</basicUdiDi>
    <tradeName>CA15-3 Rapid Quantitative Test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0506005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:58:15.933Z</lastUpdated>
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    <udiDi>06933260207350</udiDi>
    <basicUdiDi>B-06933260207350</basicUdiDi>
    <tradeName>CA15-3 Rapid Quantitative Test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0506004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:58:13.533Z</lastUpdated>
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    <udiDi>06933260207343</udiDi>
    <basicUdiDi>B-06933260207343</basicUdiDi>
    <tradeName>CA15-3 Rapid Quantitative Test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0506003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:58:12.329Z</lastUpdated>
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    <udiDi>06933260207336</udiDi>
    <basicUdiDi>B-06933260207336</basicUdiDi>
    <tradeName>CA15-3 Rapid Quantitative Test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0506002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:58:11.143Z</lastUpdated>
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    <udiDi>06933260207329</udiDi>
    <basicUdiDi>B-06933260207329</basicUdiDi>
    <tradeName>CA15-3 Rapid Quantitative Test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0506001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:58:09.932Z</lastUpdated>
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    <udiDi>00816870022185</udiDi>
    <basicUdiDi>081687002CA1535675S4</basicUdiDi>
    <tradeName>CA 15-3 AccuLite CLIA Kit - 192 wells</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5675-300B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.193Z</lastUpdated>
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    <udiDi>00630414461328</udiDi>
    <basicUdiDi>0405686901801VL</basicUdiDi>
    <tradeName>ADVIA Centaur® CA 15-3®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10312831</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T13:35:39.084Z</lastUpdated>
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