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    <tradeName>Carbonhydrate Antigen 19-9 (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>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970341685805</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:13:29.727Z</lastUpdated>
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    <udiDi>06936700404784</udiDi>
    <basicUdiDi>697029753278LZ</basicUdiDi>
    <tradeName>Cancer Antigen 19-9 test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Cancer Antigen 19-9 test (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Hotgen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015566</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGCL28</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:08:49.686Z</lastUpdated>
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    <udiDi>06942359549592</udiDi>
    <basicUdiDi>697015090000010GK</basicUdiDi>
    <tradeName>CA19-9 CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMB0803</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:03:58.900Z</lastUpdated>
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    <udiDi>06942359516860</udiDi>
    <basicUdiDi>697015090000010GK</basicUdiDi>
    <tradeName>CA19-9 CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMB0807</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:48:10.377Z</lastUpdated>
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    <udiDi>06944904047713</udiDi>
    <basicUdiDi>69449040004H-CA19-9****M7</basicUdiDi>
    <tradeName>Carbohydrate Antigen 19-9 (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>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004217-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:44:24.429Z</lastUpdated>
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    <udiDi>06925912711629</udiDi>
    <basicUdiDi>692591270026H3</basicUdiDi>
    <tradeName>iFlash-CA 19-9</tradeName>
    <deviceName>iFlash-CA 19-9</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>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86007-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:29:07.345Z</lastUpdated>
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    <udiDi>06925794588302</udiDi>
    <basicUdiDi>69257945W0102030103R0LV</basicUdiDi>
    <tradeName>Cancer Antigen 19-9 Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Cancer Antigen 19-9 Detection Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013798</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:28:16.787Z</lastUpdated>
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    <udiDi>04260157631878</udiDi>
    <basicUdiDi>426015763807BCA19-9K0XXUJ</basicUdiDi>
    <tradeName>B·R·A·H·M·S CA 19-9 KRYPTOR</tradeName>
    <deviceName>B·R·A·H·M·S CA 19-9 KRYPTOR</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>807100N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:33:53.660Z</lastUpdated>
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    <udiDi>03573026065126</udiDi>
    <basicUdiDi>357302BUDI000240SY</basicUdiDi>
    <tradeName>VIDAS® CA 19-9™</tradeName>
    <deviceName>VIDAS® CA 19-9™</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30427</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:48:43.461Z</lastUpdated>
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  <row>
    <udiDi>15099590218690</udiDi>
    <basicUdiDi>150995905CA19-9IRMARN</basicUdiDi>
    <tradeName>IRMA CA 19-9 antigen</tradeName>
    <deviceName>IRMA CA 19-9 antigen</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM3151, B64313</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:45:19.270Z</lastUpdated>
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  <row>
    <udiDi>00816870022208</udiDi>
    <basicUdiDi>081687002CA1993975VT</basicUdiDi>
    <tradeName>CA 19-9 AccuLite CLIA Kit - 192 wells</tradeName>
    <deviceName>Cancer Antigen 19-9 (CA 19-9) AccuLite® CLIA Test System</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>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3975-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:57:35.501Z</lastUpdated>
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    <udiDi>00816870022192</udiDi>
    <basicUdiDi>081687002CA1993975VT</basicUdiDi>
    <tradeName>CA 19-9 AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName>Cancer Antigen 19-9 (CA 19-9) AccuLite® CLIA Test System</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>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3975-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:56:09.163Z</lastUpdated>
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    <udiDi>06971348762261</udiDi>
    <basicUdiDi>B-06971348762261</basicUdiDi>
    <tradeName>Carbohydrate Antigen 19-9 (CA19-9) Diagnostic Kit(Immunochromatographic Assay)</tradeName>
    <deviceName>Carbohydrate Antigen 19-9 (CA19-9) Diagnostic Kit(Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-04-25</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:53:17.258Z</lastUpdated>
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    <udiDi>06971348760090</udiDi>
    <basicUdiDi>B-06971348760090</basicUdiDi>
    <tradeName>Carbohydrate Antigen 19-9 (CA19-9) Diagnostic Kit(Immunochromatographic Assay)</tradeName>
    <deviceName>Carbohydrate Antigen 19-9 (CA19-9) Diagnostic Kit(Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-04-20</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:52:06.759Z</lastUpdated>
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    <udiDi>D-R163162S</udiDi>
    <basicUdiDi>B-R163162S</basicUdiDi>
    <tradeName>D-R163162S</tradeName>
    <deviceName>Carbohydrate Antigen 19-9 (CA19-9) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R16316</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:04:31.982Z</lastUpdated>
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    <udiDi>D-R163152Q</udiDi>
    <basicUdiDi>B-R163152Q</basicUdiDi>
    <tradeName>D-R163152Q</tradeName>
    <deviceName>Carbohydrate Antigen 19-9 (CA19-9) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R16315</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:04:30.897Z</lastUpdated>
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    <udiDi>D-R163142N</udiDi>
    <basicUdiDi>B-R163142N</basicUdiDi>
    <tradeName>D-R163142N</tradeName>
    <deviceName>Carbohydrate Antigen 19-9 (CA19-9) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R16314</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:04:30.097Z</lastUpdated>
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    <udiDi>D-R163132L</udiDi>
    <basicUdiDi>B-R163132L</basicUdiDi>
    <tradeName>D-R163132L</tradeName>
    <deviceName>Carbohydrate Antigen 19-9 (CA19-9) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R16313</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:04:29.357Z</lastUpdated>
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    <udiDi>D-R163122J</udiDi>
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    <tradeName>D-R163122J</tradeName>
    <deviceName>Carbohydrate Antigen 19-9 (CA19-9) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R16312</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:04:25.285Z</lastUpdated>
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  <row>
    <udiDi>D-R163112G</udiDi>
    <basicUdiDi>B-R163112G</basicUdiDi>
    <tradeName>D-R163112G</tradeName>
    <deviceName>Carbohydrate Antigen 19-9 (CA19-9) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R16311</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:04:24.501Z</lastUpdated>
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