<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-5B03C1US</udiDi>
    <basicUdiDi>B-5B03C1US</basicUdiDi>
    <tradeName>Free Triiodothyronine Test (FIA)</tradeName>
    <deviceName>Free Triiodothyronine Test (FIA)</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>W0102160999</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5B03C1-25-EU, 5B03C1-50-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:06:13.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5B02C1UM</udiDi>
    <basicUdiDi>B-5B02C1UM</basicUdiDi>
    <tradeName>Free Thyroxine Test (FIA)</tradeName>
    <deviceName>Free Thyroxine Test (FIA)</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>W0102160999</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5B02C1-25-EU, 5B02C1-50-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:06:11.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5B01C1UG</udiDi>
    <basicUdiDi>B-5B01C1UG</basicUdiDi>
    <tradeName>Thyroid Stimulating Hormone Test (FIA)</tradeName>
    <deviceName>Thyroid Stimulating Hormone Test (FIA)</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>W0102160903</emdnCode>
    <emdnDescription>THYROID-STIMULATING HORMONE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5B01C1-25-EU, 5B01C1-50-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:06:10.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977194142547</udiDi>
    <basicUdiDi>B-06977194142547</basicUdiDi>
    <tradeName>06977194142547</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160999</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0528002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:36:04.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260173434224</udiDi>
    <basicUdiDi>B-04260173434224</basicUdiDi>
    <tradeName>ZuhauseTEST TSH Rapid Test Cassette</tradeName>
    <deviceName>ZuhauseTEST TSH Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160903</emdnCode>
    <emdnDescription>THYROID-STIMULATING HORMONE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OTS-402H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:12:52.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TSH-C06aPU</udiDi>
    <basicUdiDi>B-TSH-C06aPU</basicUdiDi>
    <tradeName>TSH Test Kit FIA</tradeName>
    <deviceName>TSH Test Kit FIA</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160903</emdnCode>
    <emdnDescription>THYROID-STIMULATING HORMONE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TSH-C06a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:23:52.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TSH-C02aPG</udiDi>
    <basicUdiDi>B-TSH-C02aPG</basicUdiDi>
    <tradeName>TSH Rapid Test</tradeName>
    <deviceName>TSH Rapid Test</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>W0102160903</emdnCode>
    <emdnDescription>THYROID-STIMULATING HORMONE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TSH-C02a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:23:51.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TSF/FOB-F22aQE</udiDi>
    <basicUdiDi>B-TSF/FOB-F22aQE</basicUdiDi>
    <tradeName>FOB-TRF Combo Rapid Test</tradeName>
    <deviceName>FOB-TRF Combo Rapid Test</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>W0102160999</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TSF/FOB-F22a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:23:47.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TSF-F02aPB</udiDi>
    <basicUdiDi>B-TSF-F02aPB</basicUdiDi>
    <tradeName>Transferrin Rapid Test</tradeName>
    <deviceName>Transferrin Rapid Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160999</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TSF-F02a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:23:46.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TFH-F32aHP</udiDi>
    <basicUdiDi>B-TFH-F32aHP</basicUdiDi>
    <tradeName>Transferrin/FOB/Hb-Hp Combo Rapid Test</tradeName>
    <deviceName>Transferrin/FOB/Hb-Hp Combo Rapid Test</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>W0102160999</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFH-F32a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:58:32.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-T4-D06aLA</udiDi>
    <basicUdiDi>B-T4-D06aLA</basicUdiDi>
    <tradeName>T4 Test Kit FIA</tradeName>
    <deviceName>T4 Test Kit FIA</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160999</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T4-D06a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:53:32.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-T3-D06aKV</udiDi>
    <basicUdiDi>B-T3-D06aKV</basicUdiDi>
    <tradeName>T3 Test Kit FIA</tradeName>
    <deviceName>T3 Test Kit FIA</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160999</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T3-D06a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:53:31.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K42-TSHK9</udiDi>
    <basicUdiDi>B-K42-TSHK9</basicUdiDi>
    <tradeName>CrinoCheck TSH</tradeName>
    <deviceName>TSH 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>W0102160903</emdnCode>
    <emdnDescription>THYROID-STIMULATING HORMONE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K42-TSH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:36:37.211Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HBA1C-D06aFH</udiDi>
    <basicUdiDi>B-HBA1C-D06aFH</basicUdiDi>
    <tradeName>HbA1C Test Kit FIA</tradeName>
    <deviceName>HbA1C Test Kit FIA</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160999</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBA1C-D06a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:52:47.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD167XW</udiDi>
    <basicUdiDi>B-GKPD167XW</basicUdiDi>
    <tradeName>TSH Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>TSH Detection Kit (Immunofluorescence Chromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160903</emdnCode>
    <emdnDescription>THYROID-STIMULATING HORMONE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD167</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:39:15.979Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT4-D06a8K</udiDi>
    <basicUdiDi>B-FT4-D06a8K</basicUdiDi>
    <tradeName>FT4 Test Kit FIA</tradeName>
    <deviceName>FT4 Test Kit FIA</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160999</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FT4-D06a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:24:28.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT3-D06a86</udiDi>
    <basicUdiDi>B-FT3-D06a86</basicUdiDi>
    <tradeName>FT3 Test Kit FIA</tradeName>
    <deviceName>FT3 Test Kit FIA</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160999</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FT3-D06a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:24:27.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FER-D06aCD</udiDi>
    <basicUdiDi>B-FER-D06aCD</basicUdiDi>
    <tradeName>Ferritin Test Kit FIA</tradeName>
    <deviceName>Ferritin Test Kit FIA</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160999</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FER-D06a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:27:10.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FER-D02aBZ</udiDi>
    <basicUdiDi>B-FER-D02aBZ</basicUdiDi>
    <tradeName>Ferritin Rapid Test</tradeName>
    <deviceName>Ferritin Rapid Test</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>W0102160999</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FER-D02a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:27:09.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-COR-J02aGU</udiDi>
    <basicUdiDi>B-COR-J02aGU</basicUdiDi>
    <tradeName>Cortisol Rapid Test</tradeName>
    <deviceName>Cortisol Rapid Test</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>W0102160999</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COR-J02a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:19:47.194Z</lastUpdated>
  </row>
</eudamedExport>