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<eudamedExport entity="devices">
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    <udiDi>06944904025230</udiDi>
    <basicUdiDi>694490400045TBA********HS</basicUdiDi>
    <tradeName>Total Bile Acids Kit (Enzymatic cycling assay)</tradeName>
    <deviceName>Total Bile Acids Kit (Enzymatic cycling assay)</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>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000867-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:43:38.676Z</lastUpdated>
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  <row>
    <udiDi>8053617721006ZK</udiDi>
    <basicUdiDi>B-8053617721006ZK</basicUdiDi>
    <tradeName>Total Bile Acid LS</tradeName>
    <deviceName>Total Bile Acid LS</deviceName>
    <manufacturerName>MTD Diagnostics srl</manufacturerName>
    <manufacturerSrn>IT-MF-000053242</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC0060</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-25T12:58:16.346Z</lastUpdated>
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  <row>
    <udiDi>06936895305491</udiDi>
    <basicUdiDi>B-06936895305491</basicUdiDi>
    <tradeName>Total Bile Acid (TBA) Test Kit (Enzymatic Cycling)</tradeName>
    <deviceName>Total Bile Acid (TBA) Test Kit (Enzymatic Cycling)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:18mL×4  R2:6mL×4（796）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:49:33.769Z</lastUpdated>
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    <udiDi>06936895305484</udiDi>
    <basicUdiDi>B-06936895305484</basicUdiDi>
    <tradeName>Total Bile Acid (TBA) Test Kit (Enzymatic Cycling)</tradeName>
    <deviceName>Total Bile Acid (TBA) Test Kit (Enzymatic Cycling)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:18mL×4  R2:6mL×4（707）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:49:32.976Z</lastUpdated>
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  <row>
    <udiDi>06936895305477</udiDi>
    <basicUdiDi>B-06936895305477</basicUdiDi>
    <tradeName>Total Bile Acid (TBA) Test Kit (Enzymatic Cycling)</tradeName>
    <deviceName>Total Bile Acid (TBA) Test Kit (Enzymatic Cycling)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:60mL×2  R2:20mL×2（794）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:49:32.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895305460</udiDi>
    <basicUdiDi>B-06936895305460</basicUdiDi>
    <tradeName>Total Bile Acid (TBA) Test Kit (Enzymatic Cycling)</tradeName>
    <deviceName>Total Bile Acid (TBA) Test Kit (Enzymatic Cycling)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:48mL×2  R2:16mL×2（716）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:47:55.196Z</lastUpdated>
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  <row>
    <udiDi>06936895305453</udiDi>
    <basicUdiDi>B-06936895305453</basicUdiDi>
    <tradeName>Total Bile Acid (TBA) Test Kit (Enzymatic Cycling)</tradeName>
    <deviceName>Total Bile Acid (TBA) Test Kit (Enzymatic Cycling)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:48mL×2  R2:32mL×1（793）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:47:54.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895305446</udiDi>
    <basicUdiDi>B-06936895305446</basicUdiDi>
    <tradeName>Total Bile Acid (TBA) Test Kit (Enzymatic Cycling)</tradeName>
    <deviceName>Total Bile Acid (TBA) Test Kit (Enzymatic Cycling)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:60ml ×1    R2:20ml×1（703）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:47:51.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R0541429</udiDi>
    <basicUdiDi>B-R0541429</basicUdiDi>
    <tradeName>D-R0541429</tradeName>
    <deviceName>Bile Acids Assay Reagent Kit (5th Generation Colorimetric Method)</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>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R05414</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:59.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R0541327</udiDi>
    <basicUdiDi>B-R0541327</basicUdiDi>
    <tradeName>D-R0541327</tradeName>
    <deviceName>Bile Acids Assay Reagent Kit (5th Generation Colorimetric Method)</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>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R05413</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:58.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R054162D</udiDi>
    <basicUdiDi>B-R054162D</basicUdiDi>
    <tradeName>D-R054162D</tradeName>
    <deviceName>Bile Acids Assay Reagent Kit (5th Generation Colorimetric Method)</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>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R05416</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:57.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R054152B</udiDi>
    <basicUdiDi>B-R054152B</basicUdiDi>
    <tradeName>D-R054152B</tradeName>
    <deviceName>Bile Acids Assay Reagent Kit (5th Generation Colorimetric Method)</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>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R05415</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:56.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R0541225</udiDi>
    <basicUdiDi>B-R0541225</basicUdiDi>
    <tradeName>D-R0541225</tradeName>
    <deviceName>Bile Acids Assay Reagent Kit (5th Generation Colorimetric Method)</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>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R05412</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:39.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R0541123</udiDi>
    <basicUdiDi>B-R0541123</basicUdiDi>
    <tradeName>D-R0541123</tradeName>
    <deviceName>Bile Acids Assay Reagent Kit (5th Generation Colorimetric Method)</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>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R05411</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:39.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-58H40TXB</udiDi>
    <basicUdiDi>B-58H40TXB</basicUdiDi>
    <tradeName>Total Bile Acids (TBA) Assay Kit (Enzymatic Cycling Method)</tradeName>
    <deviceName>Total Bile Acids (TBA) Assay Kit (Enzymatic Cycling Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>58H40T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:57:44.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-58H40TSCV5</udiDi>
    <basicUdiDi>B-58H40TSCV5</basicUdiDi>
    <tradeName>Total Bile Acids (TBA) Assay Kit (Enzymatic Cycling Method)</tradeName>
    <deviceName>Total Bile Acids (TBA) Assay Kit (Enzymatic Cycling Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>58H40TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:57:42.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-58H240TSCBD</udiDi>
    <basicUdiDi>B-58H240TSCBD</basicUdiDi>
    <tradeName>Total Bile Acids (TBA) Assay Kit (Enzymatic Cycling Method)</tradeName>
    <deviceName>Total Bile Acids (TBA) Assay Kit (Enzymatic Cycling Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>58H240TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:57:42.021Z</lastUpdated>
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  <row>
    <udiDi>D-58H240TAR</udiDi>
    <basicUdiDi>B-58H240TAR</basicUdiDi>
    <tradeName>Total Bile Acids (TBA) Assay Kit (Enzymatic Cycling Method)</tradeName>
    <deviceName>Total Bile Acids (TBA) Assay Kit (Enzymatic Cycling Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>58H240T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:57:40.431Z</lastUpdated>
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  <row>
    <udiDi>D-KHB1099P</udiDi>
    <basicUdiDi>B-KHB1099P</basicUdiDi>
    <tradeName>D-KHB1099P</tradeName>
    <deviceName>Total Bile Acids Kit (Enzyme Cycling Method)</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:39:17.455Z</lastUpdated>
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    <udiDi>D-ECH01030054T</udiDi>
    <basicUdiDi>B-ECH01030054T</basicUdiDi>
    <tradeName>D-ECH01030054T</tradeName>
    <deviceName>Total Bile Acids (TBA) Assay Kit by Enzyme Cycle Method</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0103005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:35:17.606Z</lastUpdated>
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</eudamedExport>