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<eudamedExport entity="devices">
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    <udiDi>D-EIM4101301DZ</udiDi>
    <basicUdiDi>B-EIM4101301DZ</basicUdiDi>
    <tradeName>D-EIM4101301DZ</tradeName>
    <deviceName>Urinary Microalbumin (mAlb) Assay Kit by Fluorescence Immunochromatographic 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>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4101301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:47:26.409Z</lastUpdated>
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  <row>
    <udiDi>D-CNM0000180725001MR</udiDi>
    <basicUdiDi>B-CNM0000180725001MR</basicUdiDi>
    <tradeName>D-CNM0000180725001MR</tradeName>
    <deviceName>One-Step Microalbuminuria(MAU) Test</deviceName>
    <manufacturerName>Shanghai Chemtron Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018072</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5001C  5001S  5001D 5001B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:10:22.534Z</lastUpdated>
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  <row>
    <udiDi>D-ABT-MAU-A305W3</udiDi>
    <basicUdiDi>B-ABT-MAU-A305W3</basicUdiDi>
    <tradeName>Accu-Tell® Micro-Albumin Semi-quantitative Strip (Urine)</tradeName>
    <deviceName>Accu-Tell® Micro-Albumin Semi-quantitative Strip (Urine)</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>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-MAU-A305</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:31.200Z</lastUpdated>
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  <row>
    <udiDi>D-811049PF</udiDi>
    <basicUdiDi>B-811049PF</basicUdiDi>
    <tradeName>D-811049PF</tradeName>
    <deviceName>MAU Rapid Detect</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>811049</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:57:42.894Z</lastUpdated>
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  <row>
    <udiDi>D-47136487608BMATYU</udiDi>
    <basicUdiDi>B-47136487608BMATYU</basicUdiDi>
    <tradeName>Eclipse PLUS</tradeName>
    <deviceName>Eclipse PLUS Microalbumin Reagent Kit</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S5641010 S5641011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:17.299Z</lastUpdated>
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  <row>
    <udiDi>42623675614257</udiDi>
    <basicUdiDi>B-42623675614257</basicUdiDi>
    <tradeName>EZ-Microalbumin Screening Test</tradeName>
    <deviceName>EZ-Microalbumin Screening Test</deviceName>
    <manufacturerName>BIOEUROPE GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000039230</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1400-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:36:10.030Z</lastUpdated>
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  <row>
    <udiDi>D-1400-1L9</udiDi>
    <basicUdiDi>B-1400-1L9</basicUdiDi>
    <tradeName>Fortel Kidney Disease (Microalbumin) Screening Test</tradeName>
    <deviceName>Fortel Kidney Disease (Microalbumin)  Screening Test</deviceName>
    <manufacturerName>BIOEUROPE GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000039230</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1400-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T03:08:04.055Z</lastUpdated>
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  <row>
    <udiDi>08800031900353</udiDi>
    <basicUdiDi>B-08800031900353</basicUdiDi>
    <tradeName>AUTODXTM U-Albumin Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DxGen Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000030876</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E1C800</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:06:46.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548250872</udiDi>
    <basicUdiDi>B-08683548250872</basicUdiDi>
    <tradeName>RapidFor™ Microalbumin Rapid Test Kit (FIA)</tradeName>
    <deviceName>Microalbumin 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>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO49</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:10:52.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979878281542</udiDi>
    <basicUdiDi>B-06979878281542</basicUdiDi>
    <tradeName>06979878281542</tradeName>
    <deviceName>Microalbumin Test (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Huzhou Jierunxin Biotechnology Co., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000047637</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001054</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:51:40.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979355921169</udiDi>
    <basicUdiDi>B-06979355921169</basicUdiDi>
    <tradeName>06979355921169</tradeName>
    <deviceName>Urinary Microalbumin (mALB)  Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:02:28.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979355921152</udiDi>
    <basicUdiDi>B-06979355921152</basicUdiDi>
    <tradeName>06979355921152</tradeName>
    <deviceName>Urinary Microalbumin (mALB)  Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:02:28.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979355921145</udiDi>
    <basicUdiDi>B-06979355921145</basicUdiDi>
    <tradeName>06979355921145</tradeName>
    <deviceName>Urinary Microalbumin (mALB)  Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:02:27.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979355921138</udiDi>
    <basicUdiDi>B-06979355921138</basicUdiDi>
    <tradeName>06979355921138</tradeName>
    <deviceName>Urinary Microalbumin (mALB)  Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:02:26.502Z</lastUpdated>
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  <row>
    <udiDi>06979355921121</udiDi>
    <basicUdiDi>B-06979355921121</basicUdiDi>
    <tradeName>06979355921121</tradeName>
    <deviceName>Urinary Microalbumin (mALB)  Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:02:22.493Z</lastUpdated>
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  <row>
    <udiDi>06979355921114</udiDi>
    <basicUdiDi>B-06979355921114</basicUdiDi>
    <tradeName>06979355921114</tradeName>
    <deviceName>Urinary Microalbumin (mALB)  Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 test/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:02:21.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139075791</udiDi>
    <basicUdiDi>B-06978139075791</basicUdiDi>
    <tradeName>Microalbumin (mAlb) Assay Kits (Lateral Flow Immunoassay)</tradeName>
    <deviceName>Microalbumin (mAlb) Assay Kits (Lateral Flow Immunoassay)</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>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>745006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:40:07.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374750381</udiDi>
    <basicUdiDi>B-06976374750381</basicUdiDi>
    <tradeName>Microalbuminuria (mAlb) Test Kit (Fluorescence immunochromatography method)</tradeName>
    <deviceName>Microalbuminuria (mAlb) 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>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests / kit（DR014-2）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:42:03.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374750374</udiDi>
    <basicUdiDi>B-06976374750374</basicUdiDi>
    <tradeName>Microalbuminuria (mAlb) Test Kit (Fluorescence immunochromatography method)</tradeName>
    <deviceName>Microalbuminuria (mAlb) 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>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests / kit（DR014-4）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:42:01.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374750367</udiDi>
    <basicUdiDi>B-06976374750367</basicUdiDi>
    <tradeName>Microalbuminuria (mAlb) Test Kit (Fluorescence immunochromatography method)</tradeName>
    <deviceName>Microalbuminuria (mAlb) 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>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests / kit（DR014-1）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:42:01.220Z</lastUpdated>
  </row>
</eudamedExport>