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    <tradeName>CanAg Glypican-3 EIA</tradeName>
    <deviceName>CanAg Glypican-3 EIA</deviceName>
    <manufacturerName>Fujirebio Diagnostics AB</manufacturerName>
    <manufacturerSrn>SE-MF-000007811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>503-10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:24:22.293Z</lastUpdated>
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    <udiDi>06925912716884</udiDi>
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    <tradeName>iFlash-PIVKA-Ⅱ</tradeName>
    <deviceName>iFlash-PIVKA-Ⅱ</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>IVDR 2017/746</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:34:55.385Z</lastUpdated>
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    <udiDi>05700573004577</udiDi>
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    <tradeName>FLEX Monoclonal Mouse Anti-Human CD10, Clone DAK-CD10, Ready-to-Use (Dako Omnis)</tradeName>
    <deviceName>FLEX Monoclonal Mouse Anti-Human CD10, Clone DAK-CD10, Ready-to-Use</deviceName>
    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000014448</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
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    <udiDi>05700573004560</udiDi>
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    <tradeName>FLEX Monoclonal Mouse Anti-Human CD246 ALK Protein, Clone OTI1A4, Ready-to-Use (Dako Omnis)</tradeName>
    <deviceName>FLEX Monoclonal Mouse Anti-Human CD246 ALK Protein, Clone OTI1A4, Ready-to-Use</deviceName>
    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000014448</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA785</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:57:03.500Z</lastUpdated>
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    <udiDi>05700573004508</udiDi>
    <basicUdiDi>570057R0301P3007C057901QD</basicUdiDi>
    <tradeName>FLEX Monoclonal Rabbit Anti-Human PMS2, Clone EP51 Ready-to-Use (Dako Omnis)</tradeName>
    <deviceName>FLEX Monoclonal Rabbit Anti-Human PMS2, Clone EP51 Ready-to-Use</deviceName>
    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000014448</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA087</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:54:06.724Z</lastUpdated>
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    <udiDi>05700573004492</udiDi>
    <basicUdiDi>570057R0301P3007C057801Q8</basicUdiDi>
    <tradeName>FLEX Monoclonal Rabbit Anti-Human MSH6, Clone EP49 Ready-to-Use (Dako Omnis)</tradeName>
    <deviceName>FLEX Monoclonal Rabbit Anti-Human MSH6, Clone EP49 Ready-to-Use</deviceName>
    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000014448</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA086</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:54:05.916Z</lastUpdated>
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    <udiDi>05700573004485</udiDi>
    <basicUdiDi>570057R0301P3007C057701Q3</basicUdiDi>
    <tradeName>FLEX Monoclonal Mouse Anti-Human MSH2, Clone FE11 Ready-to-Use (Dako Omnis)</tradeName>
    <deviceName>FLEX Monoclonal Mouse Anti-Human MSH2, Clone FE11 Ready-to-Use</deviceName>
    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000014448</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA085</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:54:01.922Z</lastUpdated>
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    <udiDi>05700573003730</udiDi>
    <basicUdiDi>570057R0301P3007C057601PW</basicUdiDi>
    <tradeName>FLEX Monoclonal Mouse Anti-Human MLH1, Clone ES05 Ready-to-Use (Dako Omnis)</tradeName>
    <deviceName>FLEX Monoclonal Mouse Anti-Human MLH1, Clone ES05 Ready-to-Use</deviceName>
    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000014448</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA079</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:54:01.123Z</lastUpdated>
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    <udiDi>05700572034230</udiDi>
    <basicUdiDi>570057R0301P3007C009401NB</basicUdiDi>
    <tradeName>FLEX Monoclonal Mouse Anti-Human Calretinin, Clone DAK-Calret 1, Ready-to-Use (Dako Omnis)</tradeName>
    <deviceName>FLEX Monoclonal Mouse Anti-Human Calretinin, Clone DAK-Calret 1, Ready-to-Use</deviceName>
    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000014448</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA627</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:53:29.885Z</lastUpdated>
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  <row>
    <udiDi>05700572033363</udiDi>
    <basicUdiDi>570057R0301P3007C009301N6</basicUdiDi>
    <tradeName>FLEX Monoclonal Mouse Anti-Human CD56, Clone 123C3, Ready-to-Use (Dako Omnis)</tradeName>
    <deviceName>FLEX Monoclonal Mouse Anti-Human CD56, Clone 123C3, Ready-to-Use</deviceName>
    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000014448</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA628</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:52:55.434Z</lastUpdated>
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    <udiDi>05700572033028</udiDi>
    <basicUdiDi>570057R0301P3007C009501NG</basicUdiDi>
    <tradeName>FLEX Monoclonal Mouse Anti-Human Melan-A, Clone A103, Ready-to-Use (Dako Omnis)</tradeName>
    <deviceName>FLEX Monoclonal Mouse Anti-Human Melan-A, Clone A103, Ready-to-Use</deviceName>
    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000014448</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA633</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:52:50.619Z</lastUpdated>
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    <udiDi>10888385000023</udiDi>
    <basicUdiDi>B-10888385000023</basicUdiDi>
    <tradeName>CellSearch Circulating Tumor Cell (CTC) Control Kit</tradeName>
    <deviceName>CellSearch Circulating Tumor Cell (CTC) Control Kit</deviceName>
    <manufacturerName>Menarini Silicon Biosystems, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000042008</manufacturerSrn>
    <authorisedRepresentativeName>Menarini Silicon Biosystems S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000034891</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7900003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:26:33.902Z</lastUpdated>
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    <udiDi>10888385000016</udiDi>
    <basicUdiDi>B-10888385000016</basicUdiDi>
    <tradeName>CellSearch Circulating Tumor Cell (CTC) Kit</tradeName>
    <deviceName>CellSearch Circulating Tumor Cell (CTC) Kit</deviceName>
    <manufacturerName>Menarini Silicon Biosystems, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000042008</manufacturerSrn>
    <authorisedRepresentativeName>Menarini Silicon Biosystems S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000034891</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7900001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:41:20.695Z</lastUpdated>
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    <udiDi>D-IM4494129MC</udiDi>
    <basicUdiDi>B-IM4494129MC</basicUdiDi>
    <tradeName>D-IM4494129MC</tradeName>
    <deviceName>PIVKA-II Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
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    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4494129</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:37:30.089Z</lastUpdated>
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    <tradeName>D-IM4493129M5</tradeName>
    <deviceName>PIVKA-II Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
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    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4493129</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:36:43.613Z</lastUpdated>
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    <udiDi>D-IM4407129JW</udiDi>
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    <tradeName>D-IM4407129JW</tradeName>
    <deviceName>PIVKA-II Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
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    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407129</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:28:33.498Z</lastUpdated>
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    <deviceName>PIVKA-II Chemiluminescent Immunoassay Kit</deviceName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4406129</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:26:27.495Z</lastUpdated>
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    <udiDi>D-IM4403129J2</udiDi>
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    <deviceName>PIVKA-II Chemiluminescent Immunoassay Kit</deviceName>
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    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403129</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:22:14.302Z</lastUpdated>
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    <udiDi>D-IM4402129HT</udiDi>
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    <tradeName>D-IM4402129HT</tradeName>
    <deviceName>PIVKA-II Chemiluminescent Immunoassay Kit</deviceName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402129</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:17:49.897Z</lastUpdated>
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    <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>
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    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86137-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:10.537Z</lastUpdated>
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