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<eudamedExport entity="devices">
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    <basicUdiDi>692591270089HT</basicUdiDi>
    <tradeName>iFlash-Laminin</tradeName>
    <deviceName>iFlash-Laminin</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86048</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:31:13.260Z</lastUpdated>
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  <row>
    <udiDi>06925912717089</udiDi>
    <basicUdiDi>692591270088HR</basicUdiDi>
    <tradeName>iFlash-Col Ⅳ</tradeName>
    <deviceName>iFlash-Col Ⅳ</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86047</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:31:12.356Z</lastUpdated>
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    <udiDi>D-A049DD</udiDi>
    <basicUdiDi>B-A049DD</basicUdiDi>
    <tradeName>D-A049DD</tradeName>
    <deviceName>INDICAID™ Liver Health CHI3L1 Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</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>INDICAID™ Liver Health CHI3L1 Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:42:54.649Z</lastUpdated>
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    <udiDi>D-6-126FJ</udiDi>
    <basicUdiDi>B-6-126FJ</basicUdiDi>
    <tradeName>D-6-126FJ</tradeName>
    <deviceName>Cholyglycine(CG)Test Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</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>"REF: USCA00000718 USCA00000719, USCA00000768 USCA00000769 USCA00000720, USCA00000767 USCA00000721, USCA00000770"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:08:26.942Z</lastUpdated>
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    <udiDi>06970150908942</udiDi>
    <basicUdiDi>B-06970150908942</basicUdiDi>
    <tradeName>LN 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMM0302</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:58:07.641Z</lastUpdated>
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  <row>
    <udiDi>06970150908935</udiDi>
    <basicUdiDi>B-06970150908935</basicUdiDi>
    <tradeName>Col IV 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMM0202</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:58:06.835Z</lastUpdated>
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    <udiDi>06970150908126</udiDi>
    <basicUdiDi>B-06970150908126</basicUdiDi>
    <tradeName>Cholylglycine 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMM0502</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:58:01.239Z</lastUpdated>
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  <row>
    <udiDi>06947145545949</udiDi>
    <basicUdiDi>69471455603WB</basicUdiDi>
    <tradeName>Biossays Cholyglycine (Latex Immunoturbidimetric）</tradeName>
    <deviceName>Cholyglycine (Latex Immunoturbidimetric）</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</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>130502023S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:42:20.338Z</lastUpdated>
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  <row>
    <udiDi>D-KR-CIV-01100CXG</udiDi>
    <basicUdiDi>B-KR-CIV-01100CXG</basicUdiDi>
    <tradeName>INNODX C IV CMIA</tradeName>
    <deviceName>INNODX C IV CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-CIV-01100C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:42:27.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912723813</udiDi>
    <basicUdiDi>692591270088HR</basicUdiDi>
    <tradeName>iFlash-Col Ⅳ</tradeName>
    <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>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86047-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:38:13.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912723820</udiDi>
    <basicUdiDi>692591270089HT</basicUdiDi>
    <tradeName>iFlash-Laminin</tradeName>
    <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>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86048-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:38:13.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145546236</udiDi>
    <basicUdiDi>69471455603WB</basicUdiDi>
    <tradeName>Biossays Cholyglycine (Latex Immunoturbidimetric）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</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>130502023A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T03:44:58.606Z</lastUpdated>
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  <row>
    <udiDi>06947145546267</udiDi>
    <basicUdiDi>69471455603WB</basicUdiDi>
    <tradeName>Biossays Cholyglycine Calibrators</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</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>160202603C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T03:44:58.586Z</lastUpdated>
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  <row>
    <udiDi>06947145546274</udiDi>
    <basicUdiDi>69471455603WB</basicUdiDi>
    <tradeName>Biossays Cholyglycine Controls</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</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>160202603Q</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T03:44:58.543Z</lastUpdated>
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    <udiDi>08683548250285</udiDi>
    <basicUdiDi>B-08683548250285</basicUdiDi>
    <tradeName>RapidFor™ Cholylglycine Rapid Test Kit (FIA)</tradeName>
    <deviceName>Cholylglycine Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO17</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:09:37.239Z</lastUpdated>
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    <udiDi>06975984063669</udiDi>
    <basicUdiDi>B-06975984063669</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>692014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:19:55.413Z</lastUpdated>
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    <udiDi>06975984063652</udiDi>
    <basicUdiDi>B-06975984063652</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>692016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:19:36.924Z</lastUpdated>
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    <udiDi>06974986814910</udiDi>
    <basicUdiDi>B-06974986814910</basicUdiDi>
    <tradeName>Collage TypeⅣ (C IV) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Collage TypeⅣ (C IV) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</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>100 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:26:34.363Z</lastUpdated>
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    <udiDi>06974986814903</udiDi>
    <basicUdiDi>B-06974986814903</basicUdiDi>
    <tradeName>Collage TypeⅣ (C IV) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Collage TypeⅣ (C IV) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</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>50 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:26:33.557Z</lastUpdated>
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    <udiDi>06974986814897</udiDi>
    <basicUdiDi>B-06974986814897</basicUdiDi>
    <tradeName>Collage TypeⅣ (C IV) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Collage TypeⅣ (C IV) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</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>25 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:26:29.552Z</lastUpdated>
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