<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-69750225319133CEN3UJ</udiDi>
    <basicUdiDi>B-69750225319133CEN3UJ</basicUdiDi>
    <tradeName>D-69750225319133CEN3UJ</tradeName>
    <deviceName>Lactate Control Solutions</deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Specification 1 、Specification 2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:16:56.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69750225319132CEMWWA</udiDi>
    <basicUdiDi>B-69750225319132CEMWWA</basicUdiDi>
    <tradeName>D-69750225319132CEMWWA</tradeName>
    <deviceName>β-Ketone Control Solutions</deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2.5mL/vial, 2 vials/box</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:16:52.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-209Y</udiDi>
    <basicUdiDi>B-6-209Y</basicUdiDi>
    <tradeName>D-6-209Y</tradeName>
    <deviceName>5'- Nucleotidase (5'-NT) quality control products</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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USCA00000705, USCA00000706"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:12:01.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-138FR</udiDi>
    <basicUdiDi>B-6-138FR</basicUdiDi>
    <tradeName>D-6-138FR</tradeName>
    <deviceName>Homocysteine quality control material</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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REF: USCA00000764、USCA00000790-USCA00000797</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:09:04.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-137FP</udiDi>
    <basicUdiDi>B-6-137FP</basicUdiDi>
    <tradeName>D-6-137FP</tradeName>
    <deviceName>Creatine Kinase MB Isoenzymes (CK-MB) quality control products</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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USCA00000623 USCA00000783 USCA00000784 USCA00000785 USCA00000786 USCA00000787 USCA00000788 USCA00000789"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:09:01.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800037901392</udiDi>
    <basicUdiDi>B-08800037901392</basicUdiDi>
    <tradeName>08800037901392</tradeName>
    <deviceName>SimplexTAS CRP Control Level 2</deviceName>
    <manufacturerName>tascom co., ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000019000</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T0303002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T20:47:52.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800037901385</udiDi>
    <basicUdiDi>B-08800037901385</basicUdiDi>
    <tradeName>08800037901385</tradeName>
    <deviceName>SimplexTAS CRP Control Level 1</deviceName>
    <manufacturerName>tascom co., ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000019000</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T0303001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T20:47:50.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SCRSV-SDK</udiDi>
    <basicUdiDi>B-SCRSV-SDK</basicUdiDi>
    <tradeName>D-SCRSV-SDK</tradeName>
    <deviceName>RSV Control</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCRSV-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:40:30.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SCROT-D-LTJ</udiDi>
    <basicUdiDi>B-SCROT-D-LTJ</basicUdiDi>
    <tradeName>D-SCROT-D-LTJ</tradeName>
    <deviceName>Rotavirus Control</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCROT-D-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:40:24.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SCNOR-D-LQQ</udiDi>
    <basicUdiDi>B-SCNOR-D-LQQ</basicUdiDi>
    <tradeName>D-SCNOR-D-LQQ</tradeName>
    <deviceName>Norovirus Control</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCNOR-D-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:40:08.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SCHPG-D-LJ6</udiDi>
    <basicUdiDi>B-SCHPG-D-LJ6</basicUdiDi>
    <tradeName>D-SCHPG-D-LJ6</tradeName>
    <deviceName>H. pylori Antigen Control</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCHPG-D-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:40:07.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SCHCG-D3C</udiDi>
    <basicUdiDi>B-SCHCG-D3C</basicUdiDi>
    <tradeName>D-SCHCG-D3C</tradeName>
    <deviceName>HCG Control</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCHCG-D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:40:02.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SCFOB-D-LEY</udiDi>
    <basicUdiDi>B-SCFOB-D-LEY</basicUdiDi>
    <tradeName>D-SCFOB-D-LEY</tradeName>
    <deviceName>Fecal Occult Blood (FOB) Control</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCFOB-D-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:39:58.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SCFFN-D-LFF</udiDi>
    <basicUdiDi>B-SCFFN-D-LFF</basicUdiDi>
    <tradeName>fFN Control</tradeName>
    <deviceName>fFN Control</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCFFN-D-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:39:53.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SCFERR-LUF</udiDi>
    <basicUdiDi>B-SCFERR-LUF</basicUdiDi>
    <tradeName>Ferritin Control</tradeName>
    <deviceName>Ferritin Control</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCFERR-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:39:52.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SCCDT-D-LF4</udiDi>
    <basicUdiDi>B-SCCDT-D-LF4</basicUdiDi>
    <tradeName>D-SCCDT-D-LF4</tradeName>
    <deviceName>Clostridium difficile Toxin A +Toxin B Control</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCCDT-D-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:39:51.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SCCAM-D-LBG</udiDi>
    <basicUdiDi>B-SCCAM-D-LBG</basicUdiDi>
    <tradeName>D-SCCAM-D-LBG</tradeName>
    <deviceName>Campylobacter Control</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCCAM-D-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:39:48.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SCADE-SZP</udiDi>
    <basicUdiDi>B-SCADE-SZP</basicUdiDi>
    <tradeName>Adenovirus pneumoniae Antigen Control</tradeName>
    <deviceName>Adenovirus Pneumoniae Antigen Control</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCADE-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:39:45.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K91201-094J</udiDi>
    <basicUdiDi>B-K91201-094J</basicUdiDi>
    <tradeName>D-K91201-094J</tradeName>
    <deviceName>C-reactive Protein (CRP) Control</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:38:42.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IC02523M</udiDi>
    <basicUdiDi>B-IC02523M</basicUdiDi>
    <tradeName>HbA1c Hemoglobin Control</tradeName>
    <deviceName>HbA1c Hemoglobin Control</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IC0252</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:04:42.525Z</lastUpdated>
  </row>
</eudamedExport>