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    <tradeName>HOKAPI™ PG I</tradeName>
    <deviceName>HOKAPI™ PG I</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>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010115001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:54:42.186Z</lastUpdated>
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    <udiDi>06939716404632</udiDi>
    <basicUdiDi>69713904301147J</basicUdiDi>
    <tradeName>HOKAPI™ HE4</tradeName>
    <deviceName>HOKAPI™ HE4</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>W0102030119</emdnCode>
    <emdnDescription>HUMAN EPIDIDYMIS PROTEIN 4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010114001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:54:41.384Z</lastUpdated>
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    <udiDi>06939716404618</udiDi>
    <basicUdiDi>69713904301137G</basicUdiDi>
    <tradeName>HOKAPI™ SCC</tradeName>
    <deviceName>HOKAPI™ SCC</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>W0102030116</emdnCode>
    <emdnDescription>SQUAMOUS CELL CARCINOMA ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010113001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:54:40.583Z</lastUpdated>
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    <udiDi>06939716404595</udiDi>
    <basicUdiDi>69713904301127E</basicUdiDi>
    <tradeName>HOKAPI™ NSE</tradeName>
    <deviceName>HOKAPI™ NSE</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>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010112001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:54:39.849Z</lastUpdated>
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    <udiDi>06939716404571</udiDi>
    <basicUdiDi>69713904301117C</basicUdiDi>
    <tradeName>HOKAPI™ CA 72-4</tradeName>
    <deviceName>HOKAPI™ CA72-4</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>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010111001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:54:38.997Z</lastUpdated>
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    <udiDi>06939716404557</udiDi>
    <basicUdiDi>69713904301107A</basicUdiDi>
    <tradeName>HOKAPI™ CYFRA 21-1</tradeName>
    <deviceName>HOKAPI™ CYFRA 21-1</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>W0102030111</emdnCode>
    <emdnDescription>CYFRA 21-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010110001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:54:38.187Z</lastUpdated>
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    <udiDi>06939716404533</udiDi>
    <basicUdiDi>69713904301097R</basicUdiDi>
    <tradeName>HOKAPI™ CA 242</tradeName>
    <deviceName>HOKAPI™ CA 242</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>W0102030108</emdnCode>
    <emdnDescription>CANCER ANTIGEN 242</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010109001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:54:37.393Z</lastUpdated>
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    <udiDi>06939716404519</udiDi>
    <basicUdiDi>69713904301087P</basicUdiDi>
    <tradeName>HOKAPI™ CA 50</tradeName>
    <deviceName>HOKAPI™ CA 50</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>W0102030104</emdnCode>
    <emdnDescription>CANCER ANTIGEN 50</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010108001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:54:36.581Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>06939716404472</udiDi>
    <basicUdiDi>69713904301067K</basicUdiDi>
    <tradeName>HOKAPI™ CA 19-9</tradeName>
    <deviceName>HOKAPI™ CA 19-9</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>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010106001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:54:34.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939716404458</udiDi>
    <basicUdiDi>69713904301057H</basicUdiDi>
    <tradeName>HOKAPI™ CA 125</tradeName>
    <deviceName>HOKAPI™ CA 125</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>W0102030106</emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010105001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:54:34.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939716404434</udiDi>
    <basicUdiDi>69713904301047F</basicUdiDi>
    <tradeName>HOKAPI™ FPSA</tradeName>
    <deviceName>HOKAPI™ FPSA</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>W0102030114</emdnCode>
    <emdnDescription>FREE PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010104001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:54:33.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939716404410</udiDi>
    <basicUdiDi>69713904301037D</basicUdiDi>
    <tradeName>HOKAPI™ PSA</tradeName>
    <deviceName>HOKAPI™ PSA</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>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010103001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:54:32.586Z</lastUpdated>
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  <row>
    <udiDi>06939716404397</udiDi>
    <basicUdiDi>69713904301027B</basicUdiDi>
    <tradeName>HOKAPI™ AFP</tradeName>
    <deviceName>HOKAPI™ AFP</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>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010102001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:54:31.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939716404373</udiDi>
    <basicUdiDi>697139043010179</basicUdiDi>
    <tradeName>HOKAPI™ CEA</tradeName>
    <deviceName>HOKAPI™ CEA</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>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010101001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:54:30.987Z</lastUpdated>
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    <udiDi>06939716404359</udiDi>
    <basicUdiDi>697139043AE1800126N</basicUdiDi>
    <tradeName>HOKAPI™ CUVETTE</tradeName>
    <deviceName>HOKAPI™ CUVETTE</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0503010203</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CUVETTES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AE20-FL00-0006</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:54:30.178Z</lastUpdated>
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    <udiDi>06939716405462</udiDi>
    <basicUdiDi>693971640905ME</basicUdiDi>
    <tradeName>HOKAPI™ FOLATE</tradeName>
    <deviceName>HOKAPI™ FOLATE</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010905001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:23:39.739Z</lastUpdated>
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    <udiDi>06939716405448</udiDi>
    <basicUdiDi>693971640902M8</basicUdiDi>
    <tradeName>HOKAPI™ VITAMIN B12</tradeName>
    <deviceName>HOKAPI™ VITAMIN B12</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010902001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:23:38.979Z</lastUpdated>
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    <udiDi>06939716405400</udiDi>
    <basicUdiDi>693971640124LA</basicUdiDi>
    <tradeName>HOKAPI™ GASTRIN-17</tradeName>
    <deviceName>HOKAPI™ GASTRIN-17</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102069001</emdnCode>
    <emdnDescription>GASTRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010124401</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:23:38.143Z</lastUpdated>
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    <udiDi>06939716405363</udiDi>
    <basicUdiDi>693971640125LC</basicUdiDi>
    <tradeName>HOKAPI™ PIVKA-II</tradeName>
    <deviceName>HOKAPI™ PIVKA-II</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>W0102039017</emdnCode>
    <emdnDescription>PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010125401</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:23:37.339Z</lastUpdated>
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</eudamedExport>