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<eudamedExport entity="devices">
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    <udiDi>06976374750060</udiDi>
    <basicUdiDi>B-06976374750060</basicUdiDi>
    <tradeName>Procalcitonin (PCT) Test Kit (Fluorescence immunochromatography method)</tradeName>
    <deviceName>Procalcitonin (PCT) Test Kit (Fluorescence immunochromatography method)</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160699</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests / kit（DR004-1）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:41:05.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374750053</udiDi>
    <basicUdiDi>B-06976374750053</basicUdiDi>
    <tradeName>Serum amyloid A (SAA) Test Kit (Fluorescence immunochromatography method)</tradeName>
    <deviceName>Serum amyloid A (SAA) Test Kit (Fluorescence immunochromatography method)</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160699</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests / kit（DR003-2）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:41:04.306Z</lastUpdated>
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  <row>
    <udiDi>06976374750046</udiDi>
    <basicUdiDi>B-06976374750046</basicUdiDi>
    <tradeName>Serum amyloid A (SAA) Test Kit (Fluorescence immunochromatography method)</tradeName>
    <deviceName>Serum amyloid A (SAA) Test Kit (Fluorescence immunochromatography method)</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160699</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests / kit（DR003-4）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:41:00.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374750039</udiDi>
    <basicUdiDi>B-06976374750039</basicUdiDi>
    <tradeName>Serum amyloid A (SAA) Test Kit (Fluorescence immunochromatography method)</tradeName>
    <deviceName>Serum amyloid A (SAA) Test Kit (Fluorescence immunochromatography method)</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160699</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests / kit（DR003-1）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:40:59.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202763200</udiDi>
    <basicUdiDi>B-06976202763200</basicUdiDi>
    <tradeName>Micro-Albumin Semi-Quantitative Rapid Test</tradeName>
    <deviceName>Micro-Albumin Semi-Quantitative Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160699</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GTMAUS-602</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:39:21.744Z</lastUpdated>
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  <row>
    <udiDi>06976202762630</udiDi>
    <basicUdiDi>B-06976202762630</basicUdiDi>
    <tradeName>Microalbumin Rapid Test</tradeName>
    <deviceName>Microalbumin Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160699</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GRMAU-A102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:37:54.435Z</lastUpdated>
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  <row>
    <udiDi>06976202762302</udiDi>
    <basicUdiDi>B-06976202762302</basicUdiDi>
    <tradeName>Microalbumin Rapid Test</tradeName>
    <deviceName>Microalbumin Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160699</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GRMAU-A102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:36:47.948Z</lastUpdated>
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  <row>
    <udiDi>06976202762142</udiDi>
    <basicUdiDi>B-06976202762142</basicUdiDi>
    <tradeName>Rota-Adenovirus Test</tradeName>
    <deviceName>Rota-Adenovirus Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160699</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIRA-622</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:36:24.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974703166346</udiDi>
    <basicUdiDi>B-06974703166346</basicUdiDi>
    <tradeName>mLabs® PCT</tradeName>
    <deviceName>mLabs® PCT</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160699</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M101-091010</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:29:18.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970581430814</udiDi>
    <basicUdiDi>B-06970581430814</basicUdiDi>
    <tradeName>Accu-Tell® Calprotectin Semi-Quantitative Cassette (Feces)</tradeName>
    <deviceName>Accu-Tell® Calprotectin Semi-Quantitative Cassette (Feces)</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160699</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-INF-B398</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:43:30.495Z</lastUpdated>
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  <row>
    <udiDi>06970581430197</udiDi>
    <basicUdiDi>B-06970581430197</basicUdiDi>
    <tradeName>Accu-Tell®PCT Semi-Quantitative Cassette(Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® PCT Semi-Quantitative Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160699</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B266</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:42:00.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339209733</udiDi>
    <basicUdiDi>B-06937339209733</basicUdiDi>
    <tradeName>Calprotectin Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160699</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VICP-602</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:57:05.001Z</lastUpdated>
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