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<eudamedExport entity="devices">
  <row>
    <udiDi>D-IM4493073M3</udiDi>
    <basicUdiDi>B-IM4493073M3</basicUdiDi>
    <tradeName>D-IM4493073M3</tradeName>
    <deviceName>Pregnancy Associated Plasma Protein-A Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050210</emdnCode>
    <emdnDescription>PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4493073</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:36:37.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4492155LX</udiDi>
    <basicUdiDi>B-IM4492155LX</basicUdiDi>
    <tradeName>D-IM4492155LX</tradeName>
    <deviceName>GDF-15 Chemiluminescent Immunoassay kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4492155</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:36:21.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4491155LQ</udiDi>
    <basicUdiDi>B-IM4491155LQ</basicUdiDi>
    <tradeName>D-IM4491155LQ</tradeName>
    <deviceName>GDF-15 Chemiluminescent Immunoassay kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4491155</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:35:42.705Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4408210JM</udiDi>
    <basicUdiDi>B-IM4408210JM</basicUdiDi>
    <tradeName>D-IM4408210JM</tradeName>
    <deviceName>Testosterone (CLIA)</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>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4408210</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:30:17.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4408209K4</udiDi>
    <basicUdiDi>B-IM4408209K4</basicUdiDi>
    <tradeName>D-IM4408209K4</tradeName>
    <deviceName>E2 (CLIA)</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>W0102050103</emdnCode>
    <emdnDescription>ESTRADIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4408209</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:30:16.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4408208K2</udiDi>
    <basicUdiDi>B-IM4408208K2</basicUdiDi>
    <tradeName>D-IM4408208K2</tradeName>
    <deviceName>Anti-Müllerian Hormone (AMH) Chemiluminescent Immunoassay Kit</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>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4408208</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:30:12.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4408207JY</udiDi>
    <basicUdiDi>B-IM4408207JY</basicUdiDi>
    <tradeName>D-IM4408207JY</tradeName>
    <deviceName>β-HCG (CLIA)</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>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4408207</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:30:11.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4408205JU</udiDi>
    <basicUdiDi>B-IM4408205JU</basicUdiDi>
    <tradeName>D-IM4408205JU</tradeName>
    <deviceName>Progesterone (CLIA)</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>W0102050106</emdnCode>
    <emdnDescription>PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4408205</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:29:55.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4408204JS</udiDi>
    <basicUdiDi>B-IM4408204JS</basicUdiDi>
    <tradeName>D-IM4408204JS</tradeName>
    <deviceName>FSH (CLIA)</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>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4408204</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:29:54.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4408203JQ</udiDi>
    <basicUdiDi>B-IM4408203JQ</basicUdiDi>
    <tradeName>D-IM4408203JQ</tradeName>
    <deviceName>PRL (CLIA)</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>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4408203</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:29:53.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4408202JN</udiDi>
    <basicUdiDi>B-IM4408202JN</basicUdiDi>
    <tradeName>D-IM4408202JN</tradeName>
    <deviceName>LH (CLIA)</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>W0102050105</emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4408202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:29:52.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4407210JE</udiDi>
    <basicUdiDi>B-IM4407210JE</basicUdiDi>
    <tradeName>D-IM4407210JE</tradeName>
    <deviceName>Testosterone (CLIA)</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>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407210</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:29:10.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4407209JV</udiDi>
    <basicUdiDi>B-IM4407209JV</basicUdiDi>
    <tradeName>D-IM4407209JV</tradeName>
    <deviceName>E2 (CLIA)</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>W0102050103</emdnCode>
    <emdnDescription>ESTRADIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407209</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:28:56.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4407208JT</udiDi>
    <basicUdiDi>B-IM4407208JT</basicUdiDi>
    <tradeName>D-IM4407208JT</tradeName>
    <deviceName>Anti-Müllerian Hormone (AMH) Chemiluminescent Immunoassay Kit</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>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407208</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:28:55.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4407204JK</udiDi>
    <basicUdiDi>B-IM4407204JK</basicUdiDi>
    <tradeName>D-IM4407204JK</tradeName>
    <deviceName>FSH (CLIA)</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>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407204</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:28:54.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4407203JH</udiDi>
    <basicUdiDi>B-IM4407203JH</basicUdiDi>
    <tradeName>D-IM4407203JH</tradeName>
    <deviceName>PRL (CLIA)</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>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407203</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:28:52.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4407202JF</udiDi>
    <basicUdiDi>B-IM4407202JF</basicUdiDi>
    <tradeName>D-IM4407202JF</tradeName>
    <deviceName>LH (CLIA)</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>W0102050105</emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:28:50.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4407155JX</udiDi>
    <basicUdiDi>B-IM4407155JX</basicUdiDi>
    <tradeName>D-IM4407155JX</tradeName>
    <deviceName>GDF-15 Chemiluminescent Immunoassay kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407155</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:28:41.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4407073JU</udiDi>
    <basicUdiDi>B-IM4407073JU</basicUdiDi>
    <tradeName>D-IM4407073JU</tradeName>
    <deviceName>Pregnancy Associated Plasma Protein-A Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050210</emdnCode>
    <emdnDescription>PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407073</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:28:14.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4407099KE</udiDi>
    <basicUdiDi>B-IM4407099KE</basicUdiDi>
    <tradeName>D-IM4407099KE</tradeName>
    <deviceName>Unconjugated Estriol Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407099</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:28:11.876Z</lastUpdated>
  </row>
</eudamedExport>