<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06925794520319</udiDi>
    <basicUdiDi>B-06925794520319</basicUdiDi>
    <tradeName>"Beta-Human Chorionic Gonadotropin Detection Kit (Chemiluminescence Immunoassay)"</tradeName>
    <deviceName>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>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013807</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:36:24.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794520296</udiDi>
    <basicUdiDi>B-06925794520296</basicUdiDi>
    <tradeName>Myoglobin Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Myoglobin 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>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013735</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:36:20.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794520272</udiDi>
    <basicUdiDi>B-06925794520272</basicUdiDi>
    <tradeName>Testosterone Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Testosterone 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>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013831</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:36:19.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794520258</udiDi>
    <basicUdiDi>B-06925794520258</basicUdiDi>
    <tradeName>Luteinizing Hormone Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Luteinizing Hormone 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>W0102050105</emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013830</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:36:18.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794520234</udiDi>
    <basicUdiDi>B-06925794520234</basicUdiDi>
    <tradeName>Antibodies to Thyroid Peroxidase Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Antibodies to Thyroid Peroxidase 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>W0102100301</emdnCode>
    <emdnDescription>THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013907</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:36:17.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794520210</udiDi>
    <basicUdiDi>B-06925794520210</basicUdiDi>
    <tradeName>Antibodies to Thyroglobulin Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Antibodies to Thyroglobulin 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>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013799</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:36:13.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794520197</udiDi>
    <basicUdiDi>B-06925794520197</basicUdiDi>
    <tradeName>Thyroid Stimulating Hormone Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Thyroid Stimulating Hormone 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>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013752</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:36:13.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794520135</udiDi>
    <basicUdiDi>B-06925794520135</basicUdiDi>
    <tradeName>Estradiol Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Estradiol 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>W0102050103</emdnCode>
    <emdnDescription>ESTRADIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013801</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:36:11.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794520111</udiDi>
    <basicUdiDi>B-06925794520111</basicUdiDi>
    <tradeName>Triiodothyronine Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Triiodothyronine 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>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013754</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:36:06.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794519788</udiDi>
    <basicUdiDi>B-06925794519788</basicUdiDi>
    <tradeName>Prolactin Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Prolactin 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>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013732</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:35:42.546Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794519764</udiDi>
    <basicUdiDi>B-06925794519764</basicUdiDi>
    <tradeName>C-Peptide Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>C-Peptide 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>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013845</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:35:41.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794519740</udiDi>
    <basicUdiDi>B-06925794519740</basicUdiDi>
    <tradeName>Progesterone Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Progesterone 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>W0102050106</emdnCode>
    <emdnDescription>PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013880</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:35:41.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794519726</udiDi>
    <basicUdiDi>B-06925794519726</basicUdiDi>
    <tradeName>Follicle Stimulating Hormone Detection Kit  (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Follicle Stimulating Hormone 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>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013838</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:35:40.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794519702</udiDi>
    <basicUdiDi>B-06925794519702</basicUdiDi>
    <tradeName>Free Triiodothyronine Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Free Triiodothyronine 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>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013859</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:35:36.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794519689</udiDi>
    <basicUdiDi>B-06925794519689</basicUdiDi>
    <tradeName>Free Thyroxine Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Free 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>W01020402</emdnCode>
    <emdnDescription>FREE THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013781</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:35:35.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794519641</udiDi>
    <basicUdiDi>B-06925794519641</basicUdiDi>
    <tradeName>B-type Natriuretic Peptide Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>B-type Natriuretic Peptide 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>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013758</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:35:33.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794519627</udiDi>
    <basicUdiDi>B-06925794519627</basicUdiDi>
    <tradeName>Procalcitonin Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Procalcitonin 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>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013855</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:35:29.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794519603</udiDi>
    <basicUdiDi>B-06925794519603</basicUdiDi>
    <tradeName>Ferritin Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Ferritin 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>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013911</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:35:29.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794519177</udiDi>
    <basicUdiDi>B-06925794519177</basicUdiDi>
    <tradeName>Cytokeratin 19 Fragments Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Cytokeratin 19 Fragments 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>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3010703</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:35:20.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794519160</udiDi>
    <basicUdiDi>B-06925794519160</basicUdiDi>
    <tradeName>Cytokeratin 19 Fragments Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Cytokeratin 19 Fragments 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>W0102030111</emdnCode>
    <emdnDescription>CYFRA 21-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3010683</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:35:16.117Z</lastUpdated>
  </row>
</eudamedExport>