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    <basicUdiDi>B-06974969982278</basicUdiDi>
    <tradeName>Collagen IV（CIV）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName>Collagen IV（CIV）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>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200 Tests/kit（DR1073-3）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:13:53.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974969981707</udiDi>
    <basicUdiDi>B-06974969981707</basicUdiDi>
    <tradeName>Collagen IV（CIV）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName>Collagen IV（CIV）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>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 Tests/kit（DR1073-2）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:11:58.161Z</lastUpdated>
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  <row>
    <udiDi>06974969981134</udiDi>
    <basicUdiDi>B-06974969981134</basicUdiDi>
    <tradeName>Collagen IV（CIV）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName>Collagen IV（CIV）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>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 Tests/kit（DR1073-1）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:10:01.227Z</lastUpdated>
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  <row>
    <udiDi>06974760129681</udiDi>
    <basicUdiDi>B-06974760129681</basicUdiDi>
    <tradeName>06974760129681</tradeName>
    <deviceName>Cholyglycine （CG）Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×60 mL, R2: 2×20 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:40:22.611Z</lastUpdated>
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    <udiDi>06978465235609</udiDi>
    <basicUdiDi>697846523ProteinB09RQ</basicUdiDi>
    <tradeName>Collagen Type IV Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Collagen Type IV Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:35:00.919Z</lastUpdated>
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  <row>
    <udiDi>06936415900564</udiDi>
    <basicUdiDi>69449040004S-C4********6S</basicUdiDi>
    <tradeName>Collagen Type IV (CLIA)</tradeName>
    <deviceName>Collagen Type IV (CLIA)</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-010718-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:12.104Z</lastUpdated>
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  <row>
    <udiDi>06936415900502</udiDi>
    <basicUdiDi>69449040004S-LN********YW</basicUdiDi>
    <tradeName>Laminin (CLIA)</tradeName>
    <deviceName>Laminin (CLIA)</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-010715-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:09.726Z</lastUpdated>
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  <row>
    <udiDi>06970341688004</udiDi>
    <basicUdiDi>B-06970341688004</basicUdiDi>
    <tradeName>Cholylglycine (CG) eCLIA</tradeName>
    <deviceName>Cholylglycine (CG) eCLIA</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>692015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:58:52.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341687991</udiDi>
    <basicUdiDi>B-06970341687991</basicUdiDi>
    <tradeName>Collagen Type IV (CIV) eCLIA</tradeName>
    <deviceName>Collagen Type IV (CIV) eCLIA</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>692013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:58:49.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685621</udiDi>
    <basicUdiDi>B-06970341685621</basicUdiDi>
    <tradeName>Cholylglycine (CG) eCLIA</tradeName>
    <deviceName>Cholylglycine (CG) eCLIA</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>692024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:57:05.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685614</udiDi>
    <basicUdiDi>B-06970341685614</basicUdiDi>
    <tradeName>Cholylglycine (CG) eCLIA</tradeName>
    <deviceName>Cholylglycine (CG) eCLIA</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>692023</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:57:03.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685607</udiDi>
    <basicUdiDi>B-06970341685607</basicUdiDi>
    <tradeName>Collagen Type IV (CIV) eCLIA</tradeName>
    <deviceName>Collagen Type IV (CIV) eCLIA</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>692022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:57:02.289Z</lastUpdated>
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  <row>
    <udiDi>06970341685591</udiDi>
    <basicUdiDi>B-06970341685591</basicUdiDi>
    <tradeName>Collagen Type IV (CIV) eCLIA</tradeName>
    <deviceName>Collagen Type IV (CIV) eCLIA</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>692021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:56:59.878Z</lastUpdated>
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  <row>
    <udiDi>06954414798524</udiDi>
    <basicUdiDi>B-06954414798524</basicUdiDi>
    <tradeName>Getein</tradeName>
    <deviceName>MAGICL CG (CLIA)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T15:33:46.910Z</lastUpdated>
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    <udiDi>06954414798494</udiDi>
    <basicUdiDi>B-06954414798494</basicUdiDi>
    <tradeName>Getein</tradeName>
    <deviceName>MAGICL CIV (CLIA)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T15:33:38.488Z</lastUpdated>
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    <udiDi>06954414798487</udiDi>
    <basicUdiDi>B-06954414798487</basicUdiDi>
    <tradeName>MAGICL PIIIP N-P (CLIA)</tradeName>
    <deviceName>MAGICL PIIIP N-P (CLIA)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T15:33:37.291Z</lastUpdated>
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    <udiDi>06950617402817</udiDi>
    <basicUdiDi>69506174IM441267E5</basicUdiDi>
    <tradeName>06950617402817</tradeName>
    <deviceName>AMA-M2 Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4415267</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:39:02.118Z</lastUpdated>
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    <udiDi>06950617402800</udiDi>
    <basicUdiDi>69506174IM441267E5</basicUdiDi>
    <tradeName>06950617402800</tradeName>
    <deviceName>AMA-M2 Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4414267</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:39:00.903Z</lastUpdated>
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    <udiDi>06950617402794</udiDi>
    <basicUdiDi>69506174IM441267E5</basicUdiDi>
    <tradeName>06950617402794</tradeName>
    <deviceName>AMA-M2 Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4411267</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:38:54.905Z</lastUpdated>
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    <udiDi>06950617402787</udiDi>
    <basicUdiDi>69506174IM441267E5</basicUdiDi>
    <tradeName>06950617402787</tradeName>
    <deviceName>AMA-M2 Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4410267</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:38:53.798Z</lastUpdated>
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