<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-ACO-FIL-402MA</udiDi>
    <basicUdiDi>B-ACO-FIL-402MA</basicUdiDi>
    <tradeName>Filariasis IgG/IgM Test Cassette</tradeName>
    <deviceName>Filariasis IgG/IgM Test Cassette</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACO-FIL-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:06:49.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACO-CRE-402LX</udiDi>
    <basicUdiDi>B-ACO-CRE-402LX</basicUdiDi>
    <tradeName>Creatinine Test Cassette</tradeName>
    <deviceName>Creatinine Test Cassette</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060112</emdnCode>
    <emdnDescription>CREATININE ANALYSIS TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACO-CRE-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:06:49.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACO-CCP-402JM</udiDi>
    <basicUdiDi>B-ACO-CCP-402JM</basicUdiDi>
    <tradeName>Anti-CCP Test Cassette</tradeName>
    <deviceName>Anti-CCP Test Cassette</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACO-CCP-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:06:47.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACO-ACR-102HS</udiDi>
    <basicUdiDi>B-ACO-ACR-102HS</basicUdiDi>
    <tradeName>Microalbumin/Creatinine Ratio Test Cassette</tradeName>
    <deviceName>Microalbumin/Creatinine Ratio Test Cassette</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060299</emdnCode>
    <emdnDescription>URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACO-ACR-102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:06:44.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-300041BUY</udiDi>
    <basicUdiDi>B-300041BUY</basicUdiDi>
    <tradeName>Ferritin Rapid Quantitative Test</tradeName>
    <deviceName>Ferritin Rapid Quantitative Test</deviceName>
    <manufacturerName>Hunan Ehome Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045177</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU-RE-F07F036001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:06:40.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-300040BUV</udiDi>
    <basicUdiDi>B-300040BUV</basicUdiDi>
    <tradeName>NT-proBNP Rapid Test Kit</tradeName>
    <deviceName>NT-proBNP Rapid Test Kit</deviceName>
    <manufacturerName>Hunan Ehome Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045177</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU-RE-F07F061001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:06:38.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-300039BVK</udiDi>
    <basicUdiDi>B-300039BVK</basicUdiDi>
    <tradeName>CK-MB Rapid Quantitative Test</tradeName>
    <deviceName>CK-MB Rapid Quantitative Test</deviceName>
    <manufacturerName>Hunan Ehome Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045177</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021311</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU-RE-F07F044001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:06:36.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-300028BVB</udiDi>
    <basicUdiDi>B-300028BVB</basicUdiDi>
    <tradeName>D-Dimer Rapid Test Kit</tradeName>
    <deviceName>D-Dimer Rapid Test Kit</deviceName>
    <manufacturerName>Hunan Ehome Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045177</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU-RE-F07F045001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:06:36.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-300027BV8</udiDi>
    <basicUdiDi>B-300027BV8</basicUdiDi>
    <tradeName>IL-6 Rapid Quantitative Test</tradeName>
    <deviceName>IL-6 Rapid Quantitative Test</deviceName>
    <manufacturerName>Hunan Ehome Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045177</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030609</emdnCode>
    <emdnDescription>INTERLEUKIN 6 (IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU-RE-F07F047001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:06:34.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-300022BUR</udiDi>
    <basicUdiDi>B-300022BUR</basicUdiDi>
    <tradeName>cTnI Rapid Test Kit</tradeName>
    <deviceName>cTnI Rapid Test Kit</deviceName>
    <manufacturerName>Hunan Ehome Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045177</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU-RE-F07F034001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:06:32.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-300021BUN</udiDi>
    <basicUdiDi>B-300021BUN</basicUdiDi>
    <tradeName>PCT (Procalcitonin) Rapid Quantitative Test</tradeName>
    <deviceName>PCT (Procalcitonin) Rapid Quantitative Test</deviceName>
    <manufacturerName>Hunan Ehome Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045177</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU-RE-F07F046001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:06:30.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-300016BUY</udiDi>
    <basicUdiDi>B-300016BUY</basicUdiDi>
    <tradeName>25-OH-VD Rapid Quantitative Test</tradeName>
    <deviceName>25-OH-VD Rapid Quantitative Test</deviceName>
    <manufacturerName>Hunan Ehome Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045177</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070206</emdnCode>
    <emdnDescription>VITAMIN D (CHOLECALCIFEROL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU-RE-F08F027001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:06:29.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-300015BUV</udiDi>
    <basicUdiDi>B-300015BUV</basicUdiDi>
    <tradeName>HbA1c Rapid Quantitative Test</tradeName>
    <deviceName>HbA1c Rapid Quantitative Test</deviceName>
    <manufacturerName>Hunan Ehome Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045177</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU-RE-F07F032001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:06:28.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>56974969798614</udiDi>
    <basicUdiDi>B-56974969798614</basicUdiDi>
    <tradeName>Interleukin 6 (IL-6) Test Kit (CLIA Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chongqing iSIA BIO-Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003364</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030609</emdnCode>
    <emdnDescription>INTERLEUKIN 6 (IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2006W</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:06:24.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>19120049208286</udiDi>
    <basicUdiDi>B-19120049208286</basicUdiDi>
    <tradeName>VACUETTE® 2 ml Virus Stabilization Tube 13x100 red cap-white ring, PREMIUM</tradeName>
    <deviceName>VACUETTE® Virus Stabilization Tube</deviceName>
    <manufacturerName>Greiner Bio-One GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024608</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>456162</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:06:23.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>19120049208262</udiDi>
    <basicUdiDi>B-19120049208262</basicUdiDi>
    <tradeName>VACUETTE® 3 ml Virus Stabilization Tube 13x100 red cap-white ring, PREMIUM</tradeName>
    <deviceName>VACUETTE® Virus Stabilization Tube</deviceName>
    <manufacturerName>Greiner Bio-One GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024608</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>456161</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:06:20.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975679490527</udiDi>
    <basicUdiDi>B-06975679490527</basicUdiDi>
    <tradeName>CRP (C-reactive protein) Rapid Quantitative Test</tradeName>
    <deviceName>CRP (C-reactive protein) Rapid Quantitative Test</deviceName>
    <manufacturerName>Hunan Ehome Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045177</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU-RE-F07F035002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-12T19:52:23.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975679490428</udiDi>
    <basicUdiDi>B-06975679490428</basicUdiDi>
    <tradeName>CK-MB Rapid Quantitative Test</tradeName>
    <deviceName>CK-MB Rapid Quantitative Test</deviceName>
    <manufacturerName>Hunan Ehome Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045177</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021311</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU-RE-F07F044002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-12T19:51:42.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>18430155002984</udiDi>
    <basicUdiDi>B-18430155002984</basicUdiDi>
    <tradeName>S. TYPHI H</tradeName>
    <deviceName>ANTIGENOS FEBRILES: S. typhi H</deviceName>
    <manufacturerName>QUIMICA CLINICA APLICADA S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001512</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011099</emdnCode>
    <emdnDescription>SALMONELLA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>990188</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-12T19:50:37.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>18430155003790</udiDi>
    <basicUdiDi>B-18430155003790</basicUdiDi>
    <tradeName>S. PARATYPHI A H</tradeName>
    <deviceName>ANTIGENOS FEBRILES: S. paratyphi A, H</deviceName>
    <manufacturerName>QUIMICA CLINICA APLICADA S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001512</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011099</emdnCode>
    <emdnDescription>SALMONELLA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>999917</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-12T19:50:37.487Z</lastUpdated>
  </row>
</eudamedExport>