<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-DKRA-ACO802ZM</udiDi>
    <basicUdiDi>B-DKRA-ACO802ZM</basicUdiDi>
    <tradeName>Kratom (KRA) Rapid Test</tradeName>
    <deviceName>Kratom (KRA) Rapid Test</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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DKRA-ACO802</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:07:37.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DBZ-R101(ACRO)VJ</udiDi>
    <basicUdiDi>B-DBZ-R101(ACRO)VJ</basicUdiDi>
    <tradeName>BZO Rapid Test Dipstick</tradeName>
    <deviceName>BZO Rapid Test Dipstick</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>W0102160504</emdnCode>
    <emdnDescription>BENZODIAZEPINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DBZ-R101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:07:36.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DBA-R101(ACRO)YJ</udiDi>
    <basicUdiDi>B-DBA-R101(ACRO)YJ</basicUdiDi>
    <tradeName>BAR Rapid Test Dipstick</tradeName>
    <deviceName>BAR Rapid Test Dipstick</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>W0102160503</emdnCode>
    <emdnDescription>BARBITURATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DBA-R101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:07:33.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DAM-R101(ACRO)D8</udiDi>
    <basicUdiDi>B-DAM-R101(ACRO)D8</basicUdiDi>
    <tradeName>AMP Rapid Test Dipstick</tradeName>
    <deviceName>AMP Rapid Test Dipstick</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>W0102160501</emdnCode>
    <emdnDescription>AMPHETAMINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DAM-R101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:07:31.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CRPDX</udiDi>
    <basicUdiDi>B-CRPDX</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-F07F035001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:07:29.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CI-SYP-ACO8Y</udiDi>
    <basicUdiDi>B-CI-SYP-ACO8Y</basicUdiDi>
    <tradeName>Syphilis Test Kit (CLIA)</tradeName>
    <deviceName>Syphilis Test Kit (CLIA)</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>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CI-SYP-ACO</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:07:29.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CCR-ACOS402VE</udiDi>
    <basicUdiDi>B-CCR-ACOS402VE</basicUdiDi>
    <tradeName>CRP Semi-quantitative Rapid Test</tradeName>
    <deviceName>CRP Semi-quantitative Rapid Test</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>W0102160601</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCR-ACOS402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:07:27.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACO-TSU-4023Y</udiDi>
    <basicUdiDi>B-ACO-TSU-4023Y</basicUdiDi>
    <tradeName>Scrub Typhus IgG/IgM Test Cassette</tradeName>
    <deviceName>Scrub Typhus 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACO-TSU-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:07:25.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACO-TPOB-4026Y</udiDi>
    <basicUdiDi>B-ACO-TPOB-4026Y</basicUdiDi>
    <tradeName>TPOAb Test Cassette</tradeName>
    <deviceName>TPOAb 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACO-TPOB-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:07:23.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACO-TG-402Q9</udiDi>
    <basicUdiDi>B-ACO-TG-402Q9</basicUdiDi>
    <tradeName>Thyroglobulin (TG) Test Cassette</tradeName>
    <deviceName>Thyroglobulin (TG) 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>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACO-TG-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:07:22.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACO-TGB-402QG</udiDi>
    <basicUdiDi>B-ACO-TGB-402QG</basicUdiDi>
    <tradeName>TGAb Test Cassette</tradeName>
    <deviceName>TGAb 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACO-TGB-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:07:21.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACO-SCTI-4023W</udiDi>
    <basicUdiDi>B-ACO-SCTI-4023W</basicUdiDi>
    <tradeName>High-Sensitivity Cardiac Troponin I</tradeName>
    <deviceName>High-Sensitivity Cardiac Troponin I</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>W0102160703</emdnCode>
    <emdnDescription>TROPONIN I/T - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACO-SCTI-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:07:18.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACO-ST2-402Q3</udiDi>
    <basicUdiDi>B-ACO-ST2-402Q3</basicUdiDi>
    <tradeName>ST2 Test Cassette</tradeName>
    <deviceName>ST2 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>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACO-ST2-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:07:16.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACO-PTH-402VP</udiDi>
    <basicUdiDi>B-ACO-PTH-402VP</basicUdiDi>
    <tradeName>PTH Test Cassette</tradeName>
    <deviceName>PTH 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>W0102060202</emdnCode>
    <emdnDescription>ANGIOTENSIN I / II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACO-PTH-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:07:02.571Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACO-NRA-635S7</udiDi>
    <basicUdiDi>B-ACO-NRA-635S7</basicUdiDi>
    <tradeName>Norovirus/Rotavirus/Adenovirus Combo Test Cassette</tradeName>
    <deviceName>Norovirus/Rotavirus/Adenovirus Combo 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>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACO-NRA-635</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:07:00.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACO-MXCR-4027P</udiDi>
    <basicUdiDi>B-ACO-MXCR-4027P</basicUdiDi>
    <tradeName>MxA/CRP Test Cassette</tradeName>
    <deviceName>MxA/CRP 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-MXCR-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:06:58.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACO-LEP-402Q8</udiDi>
    <basicUdiDi>B-ACO-LEP-402Q8</basicUdiDi>
    <tradeName>Leptospira IgG/IgM Test Cassette</tradeName>
    <deviceName>Leptospira 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACO-LEP-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:06:57.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACO-HSV2-402X2</udiDi>
    <basicUdiDi>B-ACO-HSV2-402X2</basicUdiDi>
    <tradeName>HSV 2 IgG/IgM Test Cassette</tradeName>
    <deviceName>HSV 2 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACO-HSV2-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:06:56.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACO-HSV1-402WP</udiDi>
    <basicUdiDi>B-ACO-HSV1-402WP</basicUdiDi>
    <tradeName>HSV 1 IgG/IgM Test Cassette</tradeName>
    <deviceName>HSV 1 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACO-HSV1-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:06:54.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACO-HGH-402L6</udiDi>
    <basicUdiDi>B-ACO-HGH-402L6</basicUdiDi>
    <tradeName>hGH Test Cassette</tradeName>
    <deviceName>hGH 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>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACO-HGH-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:06:52.631Z</lastUpdated>
  </row>
</eudamedExport>