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    <udiDi>06925794523556</udiDi>
    <basicUdiDi>B-06925794523556</basicUdiDi>
    <tradeName>Control for Body Liquid</tradeName>
    <deviceName>Control for Body Liquid</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016128</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:37:29.113Z</lastUpdated>
  </row>
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    <udiDi>06925794523549</udiDi>
    <basicUdiDi>B-06925794523549</basicUdiDi>
    <tradeName>Control for Body Liquid</tradeName>
    <deviceName>Control for Body Liquid</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016134</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:37:28.296Z</lastUpdated>
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    <udiDi>06925794523440</udiDi>
    <basicUdiDi>B-06925794523440</basicUdiDi>
    <tradeName>Thyroxine Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Thyroxine Detection Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020407</emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013827</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:37:27.509Z</lastUpdated>
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    <udiDi>06925794523419</udiDi>
    <basicUdiDi>B-06925794523419</basicUdiDi>
    <tradeName>Human Epididymal Protein 4 Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Human Epididymal Protein 4 Detection Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030119</emdnCode>
    <emdnDescription>HUMAN EPIDIDYMIS PROTEIN 4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013429</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:37:23.510Z</lastUpdated>
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  <row>
    <udiDi>06925794523396</udiDi>
    <basicUdiDi>B-06925794523396</basicUdiDi>
    <tradeName>Human Epididymal Protein 4 Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Human Epididymal Protein 4 Detection Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030119</emdnCode>
    <emdnDescription>HUMAN EPIDIDYMIS PROTEIN 4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013420</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:37:22.715Z</lastUpdated>
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    <udiDi>06925794523075</udiDi>
    <basicUdiDi>B-06925794523075</basicUdiDi>
    <tradeName>Tumor Marker Multi Control  Ⅱ</tradeName>
    <deviceName>Tumor Marker Multi Control  Ⅱ</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013953</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:37:21.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794523044</udiDi>
    <basicUdiDi>B-06925794523044</basicUdiDi>
    <tradeName>Free Beta-Human Chorionic Gonadotropin Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Free Beta-Human Chorionic Gonadotropin Detection Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050213</emdnCode>
    <emdnDescription>FREE BETA HCG (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013981</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:37:21.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794523037</udiDi>
    <basicUdiDi>B-06925794523037</basicUdiDi>
    <tradeName>Free Beta-Human Chorionic Gonadotropin Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Free Beta-Human Chorionic Gonadotropin Detection Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050213</emdnCode>
    <emdnDescription>FREE BETA HCG (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3014015</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:37:17.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794522863</udiDi>
    <basicUdiDi>B-06925794522863</basicUdiDi>
    <tradeName>Urinalysis Strips</tradeName>
    <deviceName>Urinalysis Strips</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>231012401001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:37:16.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794522856</udiDi>
    <basicUdiDi>B-06925794522856</basicUdiDi>
    <tradeName>Urinalysis Strips</tradeName>
    <deviceName>Urinalysis Strips</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>231010101001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:37:15.529Z</lastUpdated>
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  <row>
    <udiDi>06925794522849</udiDi>
    <basicUdiDi>B-06925794522849</basicUdiDi>
    <tradeName>Urinalysis Strips</tradeName>
    <deviceName>Urinalysis Strips</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>231011201001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:37:14.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794522832</udiDi>
    <basicUdiDi>B-06925794522832</basicUdiDi>
    <tradeName>Urinalysis Strips</tradeName>
    <deviceName>Urinalysis Strips</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>231010601001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:37:10.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794522825</udiDi>
    <basicUdiDi>B-06925794522825</basicUdiDi>
    <tradeName>Urinalysis Strips</tradeName>
    <deviceName>Urinalysis Strips</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>231011401001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:37:09.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794521828</udiDi>
    <basicUdiDi>B-06925794521828</basicUdiDi>
    <tradeName>Cardiac Marker Multi Control</tradeName>
    <deviceName>Cardiac Marker Multi Control</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152004</emdnCode>
    <emdnDescription>CARDIAC MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013949</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:37:09.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794521811</udiDi>
    <basicUdiDi>B-06925794521811</basicUdiDi>
    <tradeName>Anti-thyroid Antibodies Control</tradeName>
    <deviceName>Anti-thyroid Antibodies Control</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013969</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:37:07.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794521804</udiDi>
    <basicUdiDi>B-06925794521804</basicUdiDi>
    <tradeName>Immunoassay Multi Control</tradeName>
    <deviceName>Immunoassay Multi Control</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013966</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:37:03.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794521798</udiDi>
    <basicUdiDi>B-06925794521798</basicUdiDi>
    <tradeName>Thyroid Function Control</tradeName>
    <deviceName>Thyroid Function Control</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013952</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:37:03.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794521231</udiDi>
    <basicUdiDi>B-06925794521231</basicUdiDi>
    <tradeName>N-terminal Peptide of Type Ⅲ Procollagen Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>N-terminal Peptide of Type Ⅲ Procollagen Detection Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102120104</emdnCode>
    <emdnDescription>PROCOLLAGEN III AMINO TERMINAL PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013984</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:36:47.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794521224</udiDi>
    <basicUdiDi>B-06925794521224</basicUdiDi>
    <tradeName>N-terminal Peptide of Type Ⅲ Procollagen Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>N-terminal Peptide of Type Ⅲ Procollagen Detection Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102120104</emdnCode>
    <emdnDescription>PROCOLLAGEN III AMINO TERMINAL PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013983</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:36:47.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794521149</udiDi>
    <basicUdiDi>B-06925794521149</basicUdiDi>
    <tradeName>Folic Acid Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Folic Acid Detection Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3014016</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:36:45.048Z</lastUpdated>
  </row>
</eudamedExport>