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<eudamedExport entity="devices">
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    <udiDi>15099590231132</udiDi>
    <basicUdiDi>150995901AcchGHRT</basicUdiDi>
    <tradeName>Access Ultrasensitive hGH Reagent Pack</tradeName>
    <deviceName>Access Ultrasensitive hGH Reagent Pack</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33580</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:34:38.901Z</lastUpdated>
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  <row>
    <udiDi>D-DC76029FK</udiDi>
    <basicUdiDi>B-DC76029FK</basicUdiDi>
    <tradeName>iStar-hGH</tradeName>
    <deviceName>iStar-hGH</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</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>DC76029</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:08:54.817Z</lastUpdated>
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  <row>
    <udiDi>06933289852678</udiDi>
    <basicUdiDi>B-06933289852678</basicUdiDi>
    <tradeName>Smarlumi</tradeName>
    <deviceName>Adrenocorticotropic Hormone (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060401</emdnCode>
    <emdnDescription>ADRENOCORTIOTROPIC HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA07P0004</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-24T21:47:34.578Z</lastUpdated>
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  <row>
    <udiDi>06933289852661</udiDi>
    <basicUdiDi>B-06933289852661</basicUdiDi>
    <tradeName>Smarlumi</tradeName>
    <deviceName>Adrenocorticotropic Hormone (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060401</emdnCode>
    <emdnDescription>ADRENOCORTIOTROPIC HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA07P0003</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-24T21:47:30.571Z</lastUpdated>
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  <row>
    <udiDi>06933289852654</udiDi>
    <basicUdiDi>B-06933289852654</basicUdiDi>
    <tradeName>Smarlumi</tradeName>
    <deviceName>Adrenocorticotropic Hormone (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060401</emdnCode>
    <emdnDescription>ADRENOCORTIOTROPIC HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA07P0002</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-24T21:47:28.974Z</lastUpdated>
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  <row>
    <udiDi>06933289852647</udiDi>
    <basicUdiDi>B-06933289852647</basicUdiDi>
    <tradeName>Smarlumi</tradeName>
    <deviceName>Adrenocorticotropic Hormone (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060401</emdnCode>
    <emdnDescription>ADRENOCORTIOTROPIC HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA07P0001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-24T21:47:28.175Z</lastUpdated>
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  <row>
    <udiDi>06971348761257</udiDi>
    <basicUdiDi>B-06971348761257</basicUdiDi>
    <tradeName>Estradiol (E2) Diagnostic Kit</tradeName>
    <deviceName>Estradiol (E2) Diagnostic Kit</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060499</emdnCode>
    <emdnDescription>ENDOCRINE HORMONES (GROWTH FACTORS) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-50-20</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-24T03:53:29.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R173162Z</udiDi>
    <basicUdiDi>B-R173162Z</basicUdiDi>
    <tradeName>D-R173162Z</tradeName>
    <deviceName>Human Growth Hormone (hGH) 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>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R17316</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:07.868Z</lastUpdated>
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  <row>
    <udiDi>D-R173152X</udiDi>
    <basicUdiDi>B-R173152X</basicUdiDi>
    <tradeName>D-R173152X</tradeName>
    <deviceName>Human Growth Hormone (hGH) 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>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R17315</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:07.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R173142V</udiDi>
    <basicUdiDi>B-R173142V</basicUdiDi>
    <tradeName>D-R173142V</tradeName>
    <deviceName>Human Growth Hormone (hGH) 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>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R17314</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:06.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R173112P</udiDi>
    <basicUdiDi>B-R173112P</basicUdiDi>
    <tradeName>D-R173112P</tradeName>
    <deviceName>Human Growth Hormone (hGH) 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>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R17311</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:02.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R173132T</udiDi>
    <basicUdiDi>B-R173132T</basicUdiDi>
    <tradeName>D-R173132T</tradeName>
    <deviceName>Human Growth Hormone (hGH) 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>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R17313</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:00.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R173122R</udiDi>
    <basicUdiDi>B-R173122R</basicUdiDi>
    <tradeName>D-R173122R</tradeName>
    <deviceName>Human Growth Hormone (hGH) 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>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R17312</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:05:59.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414966113</udiDi>
    <basicUdiDi>0405686901389W3</basicUdiDi>
    <tradeName>IMMULITE 2000 IGFBP-3</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_KIT_IGFBP-3</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>W0102060406</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381447</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T06:09:52.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414601236</udiDi>
    <basicUdiDi>0405686901390VL</basicUdiDi>
    <tradeName>IMMULITE 2000 IGF-I</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_KIT_IGF-I</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>W0102060403</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR I (SOMATOMEDIN C)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11128543</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T06:08:53.286Z</lastUpdated>
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  <row>
    <udiDi>00630414960999</udiDi>
    <basicUdiDi>0405686901362VF</basicUdiDi>
    <tradeName>IMMULITE 2000 ACTH</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_ACTH</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>W0102060401</emdnCode>
    <emdnDescription>ADRENOCORTIOTROPIC HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381468</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:40:37.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76338G3</udiDi>
    <basicUdiDi>B-DC76338G3</basicUdiDi>
    <tradeName>iStar-hGH</tradeName>
    <deviceName>iStar-hGH</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</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>DC76338</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:59:49.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76337FZ</udiDi>
    <basicUdiDi>B-DC76337FZ</basicUdiDi>
    <tradeName>iStar-hGH</tradeName>
    <deviceName>iStar-hGH</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</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>DC76337</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:59:47.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76336FX</udiDi>
    <basicUdiDi>B-DC76336FX</basicUdiDi>
    <tradeName>iStar-hGH</tradeName>
    <deviceName>iStar-hGH</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</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>DC76336</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:59:44.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-105FA</udiDi>
    <basicUdiDi>B-6-105FA</basicUdiDi>
    <tradeName>D-6-105FA</tradeName>
    <deviceName>Human Growth Hormone (hGH) Assay Kit (Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</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>"REF: USIA00000113M, USIA00000114M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:07:50.368Z</lastUpdated>
  </row>
</eudamedExport>