<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936983104784</udiDi>
    <basicUdiDi>6970277510014LYJ</basicUdiDi>
    <tradeName>PCT Rapid Test</tradeName>
    <deviceName>PCT Rapid Test</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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160999</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPC-N402-10</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:09:50.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936983104760</udiDi>
    <basicUdiDi>6970277510000XYR</basicUdiDi>
    <tradeName>PCT Rapid Test</tradeName>
    <deviceName>PCT Rapid Test</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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160999</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPC-N302-10</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:57:03.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260211777</udiDi>
    <basicUdiDi>B-06933260211777</basicUdiDi>
    <tradeName>AMH Rapid Quantitative Test (Fluorescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</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>Artık piyasada değil</deviceStatus>
    <reference>BT2213</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:56:36.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935784460600</udiDi>
    <basicUdiDi>B-06935784460600</basicUdiDi>
    <tradeName>06935784460600</tradeName>
    <deviceName>PCT/CRP Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>BF-S161</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-19T04:57:50.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S165RY</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S165RY</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S165RY</tradeName>
    <deviceName>PCT/CRP Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>BF-S165</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:51:48.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S164RW</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S164RW</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S164RW</tradeName>
    <deviceName>PCT/CRP Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>BF-S164</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:51:46.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S163RU</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S163RU</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S163RU</tradeName>
    <deviceName>PCT/CRP Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>BF-S163</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:51:45.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S162RS</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S162RS</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S162RS</tradeName>
    <deviceName>PCT/CRP Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>BF-S162</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:51:40.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5M17C2ZG</udiDi>
    <basicUdiDi>B-5M17C2ZG</basicUdiDi>
    <tradeName>Procalcitonin Test (FIA)</tradeName>
    <deviceName>Procalcitonin 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>5M17C2-25-EU, 5M17C2-50-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:07:07.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5C07C1VR</udiDi>
    <basicUdiDi>B-5C07C1VR</basicUdiDi>
    <tradeName>Ferritin Test (FIA)</tradeName>
    <deviceName>Ferritin 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>5C07C1-25-EU, 5C07C1-50-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:06:23.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5B05C1V4</udiDi>
    <basicUdiDi>B-5B05C1V4</basicUdiDi>
    <tradeName>Total Thyroxine Test (FIA)</tradeName>
    <deviceName>Total 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>5B05C1-25-EU, 5B05C1-50-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:06:18.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5B04C1UX</udiDi>
    <basicUdiDi>B-5B04C1UX</basicUdiDi>
    <tradeName>Total Triiodothyronine Test (FIA)</tradeName>
    <deviceName>Total 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>5B04C1-25-EU, 5B04C1-50-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:06:14.651Z</lastUpdated>
  </row>
  <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>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>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>
</eudamedExport>