<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08056771200172</udiDi>
    <basicUdiDi>B-08056771200172</basicUdiDi>
    <tradeName>LIAISON® IGF-I</tradeName>
    <deviceName>LIAISON® IGF-I</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060403</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR I (SOMATOMEDIN C)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>313231</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:32:01.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056771100458</udiDi>
    <basicUdiDi>B-08056771100458</basicUdiDi>
    <tradeName>LIAISON® hGH</tradeName>
    <deviceName>LIAISON® hGH</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>310340</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:31:47.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056771102728</udiDi>
    <basicUdiDi>80567713187005R</basicUdiDi>
    <tradeName>LIAISON® FGF 23</tradeName>
    <deviceName>LIAISON® FGF 23</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060499</emdnCode>
    <emdnDescription>ENDOCRINE HORMONES (GROWTH FACTORS) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>318700</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:08:00.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414961552</udiDi>
    <basicUdiDi>0405686901387VX</basicUdiDi>
    <tradeName>IMMULITE 2000 Growth Hormone (hGH)</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_KIT_hGH</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381451</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:25:49.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID81-FD</udiDi>
    <basicUdiDi>B-VID81-FD</basicUdiDi>
    <tradeName>B-type Brain Natriuretic Peptide Test Kit</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>IVDD</legislation>
    <emdnCode>W0102060499</emdnCode>
    <emdnDescription>ENDOCRINE HORMONES (GROWTH FACTORS) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID81- 01-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:23:31.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID73-FE</udiDi>
    <basicUdiDi>B-VID73-FE</basicUdiDi>
    <tradeName>Human Growth Hormone Test Kit</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>IVDD</legislation>
    <emdnCode>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID73- 05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:23:19.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-403Z</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-403Z</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-403Z</tradeName>
    <deviceName>Insulin-like Growth Factor Binding Protein 3 Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060406</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:45.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-394G</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-394G</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-394G</tradeName>
    <deviceName>Insulin-like Growth Factor Binding Protein 1 Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060405</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:43.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-384E</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-384E</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-384E</tradeName>
    <deviceName>Insulin-like Growth Factor I Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060403</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR I (SOMATOMEDIN C)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:42.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-374C</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-374C</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-374C</tradeName>
    <deviceName>Vascular Endothelial Growth Factor Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060499</emdnCode>
    <emdnDescription>ENDOCRINE HORMONES (GROWTH FACTORS) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:41.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-3242</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-3242</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-3242</tradeName>
    <deviceName>Human Growth Hormone Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:31.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R2231527</udiDi>
    <basicUdiDi>B-R2231527</basicUdiDi>
    <tradeName>D-R2231527</tradeName>
    <deviceName>Soluble Growth Stimulation Expression Gene 2 Protein (ST2) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060404</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R22315</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:38.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R2231323</udiDi>
    <basicUdiDi>B-R2231323</basicUdiDi>
    <tradeName>D-R2231323</tradeName>
    <deviceName>Soluble Growth Stimulation Expression Gene 2 Protein (ST2) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060404</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R22313</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:34.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R2231425</udiDi>
    <basicUdiDi>B-R2231425</basicUdiDi>
    <tradeName>D-R2231425</tradeName>
    <deviceName>Soluble Growth Stimulation Expression Gene 2 Protein (ST2) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060404</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R22314</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:33.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R22312ZW</udiDi>
    <basicUdiDi>B-R22312ZW</basicUdiDi>
    <tradeName>D-R22312ZW</tradeName>
    <deviceName>Soluble Growth Stimulation Expression Gene 2 Protein (ST2) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060404</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R22312</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:32.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R22311ZU</udiDi>
    <basicUdiDi>B-R22311ZU</basicUdiDi>
    <tradeName>D-R22311ZU</tradeName>
    <deviceName>Soluble Growth Stimulation Expression Gene 2 Protein (ST2) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060404</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R22311</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:32.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-hGH-0250AW</udiDi>
    <basicUdiDi>B-KR-hGH-0250AW</basicUdiDi>
    <tradeName>INNODX hGH CMIA</tradeName>
    <deviceName>INNODX hGH CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-hGH-0250</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:47:26.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-hGH-02200AP</udiDi>
    <basicUdiDi>B-KR-hGH-02200AP</basicUdiDi>
    <tradeName>INNODX hGH CMIA</tradeName>
    <deviceName>INNODX hGH CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-hGH-02200</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:47:25.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-hGH-01100AB</udiDi>
    <basicUdiDi>B-KR-hGH-01100AB</basicUdiDi>
    <tradeName>INNODX hGH CMIA</tradeName>
    <deviceName>INNODX hGH CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-hGH-01100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:47:21.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4408206JW</udiDi>
    <basicUdiDi>B-IM4408206JW</basicUdiDi>
    <tradeName>D-IM4408206JW</tradeName>
    <deviceName>human Growth Hormone (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>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4408206</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:30:13.622Z</lastUpdated>
  </row>
</eudamedExport>