<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-DC76025FB</udiDi>
    <basicUdiDi>B-DC76025FB</basicUdiDi>
    <tradeName>iStar-Pepsinogen I</tradeName>
    <deviceName>iStar-Pepsinogen I</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>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76025</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:03:04.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76015F8</udiDi>
    <basicUdiDi>B-DC76015F8</basicUdiDi>
    <tradeName>iStar-25-OH Vitamin D</tradeName>
    <deviceName>iStar-25-OH Vitamin D</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76015</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:02:42.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76014F6</udiDi>
    <basicUdiDi>B-DC76014F6</basicUdiDi>
    <tradeName>iStar-PCT</tradeName>
    <deviceName>iStar-PCT</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76014</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:02:40.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CT706-AE58</udiDi>
    <basicUdiDi>B-CT706-AE58</basicUdiDi>
    <tradeName>CT Calcitonin (CLIA)</tradeName>
    <deviceName>CT Calcitonin (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060301</emdnCode>
    <emdnDescription>CALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CT706-AE10Y, CT706-AE10N, CT706-AE20Y, CT706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T10:34:17.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-COR706-AEZK</udiDi>
    <basicUdiDi>B-COR706-AEZK</basicUdiDi>
    <tradeName>Cortisol (CLIA)</tradeName>
    <deviceName>Cortisol (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COR706-AE10Y, COR706-AE10N, COR706-AE20Y, COR706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:19:47.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CN-MF-000013251RC</udiDi>
    <basicUdiDi>B-CN-MF-000013251RC</basicUdiDi>
    <tradeName>D-CN-MF-000013251RC</tradeName>
    <deviceName>PG I Reagent Kit</deviceName>
    <manufacturerName>Virtue Diagnostics (Suzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013251</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>12001008,12001048</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:09:12.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C-P706-AECW</udiDi>
    <basicUdiDi>B-C-P706-AECW</basicUdiDi>
    <tradeName>C-P C-Peptide (CLIA)</tradeName>
    <deviceName>C-P C-Peptide (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C-P706-AE10Y, C-P706-AE10N, C-P706-AE20Y, C-P706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:46:08.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ALD706-AENW</udiDi>
    <basicUdiDi>B-ALD706-AENW</basicUdiDi>
    <tradeName>ALD Aldosterone (CLIA)</tradeName>
    <deviceName>ALD Aldosterone (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060201</emdnCode>
    <emdnDescription>ALDOSTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ALD706-AE10Y, ALD706-AE10N, ALD706-AE20Y, ALD706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:35:05.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AL-1572Y</udiDi>
    <basicUdiDi>B-AL-1572Y</basicUdiDi>
    <tradeName>D-AL-1572Y</tradeName>
    <deviceName>AL-157 Gucagon ELISA (CE)</deviceName>
    <manufacturerName>Ansh Labs</manufacturerName>
    <manufacturerSrn>US-MF-000054510</manufacturerSrn>
    <authorisedRepresentativeName>QNET B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002695</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069099</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AL-157</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:34:29.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACTH706-AERL</udiDi>
    <basicUdiDi>B-ACTH706-AERL</basicUdiDi>
    <tradeName>ACTH Adrenocorticotropic Hormone (CLIA)</tradeName>
    <deviceName>ACTH Adrenocorticotropic Hormone (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060299</emdnCode>
    <emdnDescription>RENAL METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACTH706-AE10Y, ACTH706-AE10N, ACTH706-AE20Y, ACTH706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:16.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060313276158</udiDi>
    <basicUdiDi>B-86060313276158</basicUdiDi>
    <tradeName>PMN-Elastase</tradeName>
    <deviceName>PMN-Elastase</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069009</emdnCode>
    <emdnDescription>ELASTASE (PANCREATIC POLYPEPTIDE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1817ELA</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:15:18.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060313274628</udiDi>
    <basicUdiDi>B-86060313274628</basicUdiDi>
    <tradeName>Pancreatic elastase</tradeName>
    <deviceName>Pancreatic elastase</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069009</emdnCode>
    <emdnDescription>ELASTASE (PANCREATIC POLYPEPTIDE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1825PELA</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:14:54.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81H40TSCT7</udiDi>
    <basicUdiDi>B-81H40TSCT7</basicUdiDi>
    <tradeName>Neutrophil Gelatinase-Associated Lipocalin (NGAL) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName>Neutrophil Gelatinase-Associated Lipocalin (NGAL) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060207</emdnCode>
    <emdnDescription>NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81H40TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:06:05.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81H160TSC9N</udiDi>
    <basicUdiDi>B-81H160TSC9N</basicUdiDi>
    <tradeName>Neutrophil Gelatinase-Associated Lipocalin (NGAL) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName>Neutrophil Gelatinase-Associated Lipocalin (NGAL) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060207</emdnCode>
    <emdnDescription>NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81H160TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:06:00.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-808174QR</udiDi>
    <basicUdiDi>B-808174QR</basicUdiDi>
    <tradeName>D-808174QR</tradeName>
    <deviceName>25-OH Vitamin D Rapid Test</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808174</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:55:14.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-808173QP</udiDi>
    <basicUdiDi>B-808173QP</basicUdiDi>
    <tradeName>D-808173QP</tradeName>
    <deviceName>25-OH VD Rapid Detect</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808173</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:55:13.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7M39FP</udiDi>
    <basicUdiDi>B-7M39FP</basicUdiDi>
    <tradeName>Calcitonin assay (CLIA)</tradeName>
    <deviceName>Calcitonin assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060301</emdnCode>
    <emdnDescription>CALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7M39V1-B-EU, 7M39U1-B-EU, 7M39P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:29:10.313Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7M22F6</udiDi>
    <basicUdiDi>B-7M22F6</basicUdiDi>
    <tradeName>HbA1c assay (CLIA)</tradeName>
    <deviceName>HbA1c assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7M22V1-B-EU, 7M22U1-B-EU, 7M22E1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:28:57.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7M17FD</udiDi>
    <basicUdiDi>B-7M17FD</basicUdiDi>
    <tradeName>Procalcitonin assay (CLIA)</tradeName>
    <deviceName>Procalcitonin assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7M17V1-B-EU, 7M17U1-B-EU, 7M17P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:28:37.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7M12F3</udiDi>
    <basicUdiDi>B-7M12F3</basicUdiDi>
    <tradeName>25-Hydroxy Vitamin D assay (CLIA)</tradeName>
    <deviceName>25-Hydroxy Vitamin D assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7M12V1-B-EU, 7M12U1-B-EU, 7M12P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:28:36.644Z</lastUpdated>
  </row>
</eudamedExport>