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    <tradeName>Carbohydrate Antigen 15-3（CA15-3）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName>Carbohydrate Antigen 15-3（CA15-3）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 Tests/kit（DR1014-1）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:09:01.879Z</lastUpdated>
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    <udiDi>06974969980045</udiDi>
    <basicUdiDi>B-06974969980045</basicUdiDi>
    <tradeName>Carbohydrate Antigen 15-3（CA15-3）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName>Carbohydrate Antigen 15-3（CA15-3）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 Tests/kit（DR1014-2）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:08:51.488Z</lastUpdated>
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    <udiDi>06974674892152</udiDi>
    <basicUdiDi>B-06974674892152</basicUdiDi>
    <tradeName>CA15-3 FIA Kit</tradeName>
    <deviceName>CA15-3 FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0045</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:13:29.663Z</lastUpdated>
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    <udiDi>06974671100434</udiDi>
    <basicUdiDi>B-06974671100434</basicUdiDi>
    <tradeName>06974671100434</tradeName>
    <deviceName>Carbohydrate Antigen 15-3 Quantitative Diagnostic Kit (CLIA)</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-CLIA-CM-B006</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:07:19.091Z</lastUpdated>
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    <udiDi>06974671100427</udiDi>
    <basicUdiDi>B-06974671100427</basicUdiDi>
    <tradeName>06974671100427</tradeName>
    <deviceName>Carbohydrate Antigen 15-3 Quantitative Diagnostic Kit (CLIA)</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-CLIA-CM-A006</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:07:15.075Z</lastUpdated>
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    <udiDi>06974671100021</udiDi>
    <basicUdiDi>B-06974671100021</basicUdiDi>
    <tradeName>06974671100021</tradeName>
    <deviceName>Carbohydrate Antigen 15-3 (CA15-3) Diagnostic Kit (TRFIA)</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-CM-A015</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:06:47.845Z</lastUpdated>
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    <udiDi>06973861684112</udiDi>
    <basicUdiDi>B-06973861684112</basicUdiDi>
    <tradeName>CA15-3 Rapid Test Kit</tradeName>
    <deviceName>CA15-3 Rapid Test Kit</deviceName>
    <manufacturerName>Anbio (Xiamen) Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023936</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02052002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:43:04.690Z</lastUpdated>
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    <udiDi>06972719604418</udiDi>
    <basicUdiDi>B-06972719604418</basicUdiDi>
    <tradeName>06972719604418</tradeName>
    <deviceName>Cancer Antigen 15-3 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:46:31.746Z</lastUpdated>
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    <udiDi>06972719604401</udiDi>
    <basicUdiDi>B-06972719604401</basicUdiDi>
    <tradeName>06972719604401</tradeName>
    <deviceName>Cancer Antigen 15-3 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:46:27.750Z</lastUpdated>
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    <udiDi>06972719602889</udiDi>
    <basicUdiDi>B-06972719602889</basicUdiDi>
    <tradeName>06972719602889</tradeName>
    <deviceName>Cancer Antigen 15-3 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:41:11.034Z</lastUpdated>
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    <udiDi>06972719602872</udiDi>
    <basicUdiDi>B-06972719602872</basicUdiDi>
    <tradeName>06972719602872</tradeName>
    <deviceName>Cancer Antigen 15-3 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:41:09.441Z</lastUpdated>
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    <udiDi>06972719602865</udiDi>
    <basicUdiDi>B-06972719602865</basicUdiDi>
    <tradeName>06972719602865</tradeName>
    <deviceName>Cancer Antigen 15-3 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:41:08.640Z</lastUpdated>
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    <udiDi>06972719600731</udiDi>
    <basicUdiDi>B-06972719600731</basicUdiDi>
    <tradeName>06972719600731</tradeName>
    <deviceName>Cancer Antigen 15-3 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>215820001</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:33:05.585Z</lastUpdated>
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    <udiDi>06971792054370</udiDi>
    <basicUdiDi>B-06971792054370</basicUdiDi>
    <tradeName>Carbohydrate Antigen 15-3 (CA15-3) Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KA002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:57:25.577Z</lastUpdated>
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    <udiDi>06944904047911</udiDi>
    <basicUdiDi>69449040004H-CA15-3****GZ</basicUdiDi>
    <tradeName>Cancer Antigen 15-3 (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</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>105-004243-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:38.945Z</lastUpdated>
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    <udiDi>06944904048260</udiDi>
    <basicUdiDi>69449040004H-CA15-3****GZ</basicUdiDi>
    <tradeName>CA15-3 Calibrators</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</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>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004285-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:30.404Z</lastUpdated>
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    <udiDi>03770024321104</udiDi>
    <basicUdiDi>B-03770024321104</basicUdiDi>
    <tradeName>03770024321104</tradeName>
    <deviceName>ELSA-CA15-3</deviceName>
    <manufacturerName>Cisbio Bioassays</manufacturerName>
    <manufacturerSrn>FR-MF-000024051</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELSA-CA15-3</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:31:25.618Z</lastUpdated>
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    <udiDi>06939716404496</udiDi>
    <basicUdiDi>69713904301077M</basicUdiDi>
    <tradeName>HOKAPI™ CA 15-3</tradeName>
    <deviceName>HOKAPI™ CA 15-3</deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010107001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:54:35.793Z</lastUpdated>
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    <udiDi>06970341685799</udiDi>
    <basicUdiDi>69703416803205027JF</basicUdiDi>
    <tradeName>Cancer Antigen 15-3 (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</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>0320500703</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:39.415Z</lastUpdated>
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    <udiDi>15099590231859</udiDi>
    <basicUdiDi>150995901AccBRMonLK</basicUdiDi>
    <tradeName>Access BR Monitor (Reagent Pack)</tradeName>
    <deviceName>Access BR Monitor (Reagent Pack)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>387620</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:37:32.440Z</lastUpdated>
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