<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-CCK-R40279</udiDi>
    <basicUdiDi>B-CCK-R40279</basicUdiDi>
    <tradeName>CK-MB Rapid Test Cassette</tradeName>
    <deviceName>CK-MB Rapid 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>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCK-R402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T20:29:01.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CBN-R4027X</udiDi>
    <basicUdiDi>B-CBN-R4027X</basicUdiDi>
    <tradeName>NT-proBNP Rapid Test Cassette</tradeName>
    <deviceName>NT-proBNP Rapid 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>W0102160704</emdnCode>
    <emdnDescription>BNP / PROBNP - RT &amp; POC (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CBN-R402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T20:29:00.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FHC-RU1023J</udiDi>
    <basicUdiDi>B-FHC-RU1023J</basicUdiDi>
    <tradeName>D-FHC-RU1023J</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-RU102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T20:00:35.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OCAL-ACOT6029Q</udiDi>
    <basicUdiDi>B-OCAL-ACOT6029Q</basicUdiDi>
    <tradeName>Calprotectin Semi-quantitative Rapid Test</tradeName>
    <deviceName>Calprotectin 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>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCAL-ACOT602</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:58:50.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SCLH-DH7</udiDi>
    <basicUdiDi>B-SCLH-DH7</basicUdiDi>
    <tradeName>LH Control</tradeName>
    <deviceName>LH Control</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>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCLH-D</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:39.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OCAR-ACO90236</udiDi>
    <basicUdiDi>B-OCAR-ACO90236</basicUdiDi>
    <tradeName>CARBA-5 Rapid Test</tradeName>
    <deviceName>CARBA-5 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCAR-ACO902</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:39.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMXG-ACO402FM</udiDi>
    <basicUdiDi>B-IMXG-ACO402FM</basicUdiDi>
    <tradeName>Monkeypox Virus Antigen Rapid Test</tradeName>
    <deviceName>Monkeypox Virus Antigen 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>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMXG-ACO402</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:21.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMXB-ACO402CN</udiDi>
    <basicUdiDi>B-IMXB-ACO402CN</basicUdiDi>
    <tradeName>Monkeypox Virus Antibody Rapid Test</tradeName>
    <deviceName>Monkeypox Virus Antibody 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>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMXB-ACO402</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:20.677Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IHP-ACO9042T</udiDi>
    <basicUdiDi>B-IHP-ACO9042T</basicUdiDi>
    <tradeName>H. pylori Rapid Test</tradeName>
    <deviceName>H. pylori 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHP-ACO904</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:14.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IHP-ACO9022P</udiDi>
    <basicUdiDi>B-IHP-ACO9022P</basicUdiDi>
    <tradeName>H. pylori Rapid Test</tradeName>
    <deviceName>H. pylori 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHP-ACO902</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:10.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IHP-ACO9012M</udiDi>
    <basicUdiDi>B-IHP-ACO9012M</basicUdiDi>
    <tradeName>H. pylori Rapid Test</tradeName>
    <deviceName>H. pylori 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHP-ACO901</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:09.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IBP-ACO502VN</udiDi>
    <basicUdiDi>B-IBP-ACO502VN</basicUdiDi>
    <tradeName>Bordetella pertussis Antigen Rapid Test</tradeName>
    <deviceName>B-IBP-ACO502VN</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>IBP-ACO502</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:18:50.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HZN-ACO001C3</udiDi>
    <basicUdiDi>B-HZN-ACO001C3</basicUdiDi>
    <tradeName>Zinc Test</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0101060299</emdnCode>
    <emdnDescription>URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HZN-ACO001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:17:22.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DTLT-ACO114FY</udiDi>
    <basicUdiDi>B-DTLT-ACO114FY</basicUdiDi>
    <tradeName>Tiletamine (TLTM) Rapid Test</tradeName>
    <deviceName>Tiletamine (TLTM) 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>DTLT-ACO114</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:17:20.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DTLT-ACO111FS</udiDi>
    <basicUdiDi>B-DTLT-ACO111FS</basicUdiDi>
    <tradeName>Tiletamine (TLTM) Rapid Test</tradeName>
    <deviceName>Tiletamine (TLTM) 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>DTLT-ACO111</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:17:19.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DTLT-ACO102FR</udiDi>
    <basicUdiDi>B-DTLT-ACO102FR</basicUdiDi>
    <tradeName>Tiletamine (TLTM) Rapid Test</tradeName>
    <deviceName>Tiletamine (TLTM) 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>DTLT-ACO102</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:17:19.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DTLT-ACO101FP</udiDi>
    <basicUdiDi>B-DTLT-ACO101FP</basicUdiDi>
    <tradeName>Tiletamine (TLTM) Rapid Test</tradeName>
    <deviceName>Tiletamine (TLTM) 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>DTLT-ACO111</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:17:14.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DTIA-ACO1142J</udiDi>
    <basicUdiDi>B-DTIA-ACO1142J</basicUdiDi>
    <tradeName>Tianeptine (TIA) Rapid Test</tradeName>
    <deviceName>Tianeptine (TIA) 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>DTIA-ACO114</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:17:13.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DTIA-ACO1112C</udiDi>
    <basicUdiDi>B-DTIA-ACO1112C</basicUdiDi>
    <tradeName>Tianeptine (TIA) Rapid Test</tradeName>
    <deviceName>Tianeptine (TIA) 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>DTIA-ACO111</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:17:12.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DTIA-ACO1022B</udiDi>
    <basicUdiDi>B-DTIA-ACO1022B</basicUdiDi>
    <tradeName>Tianeptine (TIA) Rapid Test</tradeName>
    <deviceName>Tianeptine (TIA) 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>DTIA-ACO102</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:17:11.969Z</lastUpdated>
  </row>
</eudamedExport>