<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-CER818VBCY</udiDi>
    <basicUdiDi>B-CER818VBCY</basicUdiDi>
    <tradeName>HPVix</tradeName>
    <deviceName>CER818VB</deviceName>
    <manufacturerName>Abcerion Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CER818VB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:02:05.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CER818RTDQ</udiDi>
    <basicUdiDi>B-CER818RTDQ</basicUdiDi>
    <tradeName>HPVix</tradeName>
    <deviceName>CER818RT</deviceName>
    <manufacturerName>Abcerion Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CER818RT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:02:04.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-B99VL</udiDi>
    <basicUdiDi>B-ABT-IDT-B99VL</basicUdiDi>
    <tradeName>Accu-Tell®Malaria P.f./Pan Cassette(Whole Blood)</tradeName>
    <deviceName>Accu-Tell® Rapid Malaria P.f. /Pan Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B99</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:29.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-B85V9</udiDi>
    <basicUdiDi>B-ABT-IDT-B85V9</basicUdiDi>
    <tradeName>Accu-Tell® Malaria P.f. Cassette(Whole Blood)</tradeName>
    <deviceName>Accu-Tell® Malaria P.f. Cassette</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B85</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:25.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-B384VS</udiDi>
    <basicUdiDi>B-ABT-IDT-B384VS</basicUdiDi>
    <tradeName>Accu-Tell® COVID-19 Antigen Cassette (Saliva/ Nasopharyngeal Swab)</tradeName>
    <deviceName>Accu-Tell® COVID-19 Antigen Cassette</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B384</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:24.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-B378VX</udiDi>
    <basicUdiDi>B-ABT-IDT-B378VX</basicUdiDi>
    <tradeName>Accu-Tell® COVID-19 Antigen Cassette (Nasal Swab/Nasopharyngeal Swab)</tradeName>
    <deviceName>Accu-Tell® COVID-19 Antigen Cassette</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B378</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:24.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-B274VJ</udiDi>
    <basicUdiDi>B-ABT-IDT-B274VJ</basicUdiDi>
    <tradeName>Accu-Tell® Dengue NS1 Antigen Cassette (Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® Dengue NS1 Antigen Cassette</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B274</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:23.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-B262VB</udiDi>
    <basicUdiDi>B-ABT-IDT-B262VB</basicUdiDi>
    <tradeName>Accu-Tell® H. pylori IgG Cassette(Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® H. pylori IgG Cassette</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B262</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:19.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-B259VN</udiDi>
    <basicUdiDi>B-ABT-IDT-B259VN</basicUdiDi>
    <tradeName>Accu-Tell® Dengue IgG/IgM/NS1 Combo Cassette (Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® Dengue IgG/IgM/NS1 Combo Cassette</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B259</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:18.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-B101UJ</udiDi>
    <basicUdiDi>B-ABT-IDT-B101UJ</basicUdiDi>
    <tradeName>Accu-Tell® Typhoid Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® Rapid Typhoid Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:17.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-A99VF</udiDi>
    <basicUdiDi>B-ABT-IDT-A99VF</basicUdiDi>
    <tradeName>Accu-Tell®Malaria P.f./Pan Strip(Whole Blood)</tradeName>
    <deviceName>Accu-Tell® Rapid Malaria P.f. /Pan Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-A99</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:16.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-A247V8</udiDi>
    <basicUdiDi>B-ABT-IDT-A247V8</basicUdiDi>
    <tradeName>Accu-Tell® Influenza A+B Strip (Swab/ Nasal Aspirate)</tradeName>
    <deviceName>Accu-Tell® Influenza A+B Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-A247</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:09.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-A226UY</udiDi>
    <basicUdiDi>B-ABT-IDT-A226UY</basicUdiDi>
    <tradeName>Accu-Tell® HAV IgM/IgG Strip(Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® HAV IgM/IgG Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B226</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:05.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-A218UZ</udiDi>
    <basicUdiDi>B-ABT-IDT-A218UZ</basicUdiDi>
    <tradeName>Accu-Tell® HAV IgM Strip (Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® HAV IgM Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-A218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:04.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-A15UF</udiDi>
    <basicUdiDi>B-ABT-IDT-A15UF</basicUdiDi>
    <tradeName>Accu-tell® Strep A Strip (Throat Swab)</tradeName>
    <deviceName>Accu-Tell® Rapid Strep A Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-A15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:03.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-A13UB</udiDi>
    <basicUdiDi>B-ABT-IDT-A13UB</basicUdiDi>
    <tradeName>Accu-Tell® H. pylori IgG Strip (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® H. pylori IgG Strip</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-A13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:25:57.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A031CS</udiDi>
    <basicUdiDi>B-A031CS</basicUdiDi>
    <tradeName>INDICAID™ GASTROINTESTINAL 3-in-1 Rapid Antigen Test</tradeName>
    <deviceName>INDICAID™ GASTROINTESTINAL 3-in-1 Rapid Antigen Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ GASTROINTESTINAL 3-in-1 Rapid Antigen Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:15:16.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A017CY</udiDi>
    <basicUdiDi>B-A017CY</basicUdiDi>
    <tradeName>INDICAID™ Mycoplasma Pneumoniae (MP) Rapid IgM Antibody Test</tradeName>
    <deviceName>INDICAID™ Mycoplasma Pneumoniae (MP) Rapid IgM Antibody Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Mycoplasma Pneumoniae (MP) Rapid IgM Antibody Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:14:23.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A016CW</udiDi>
    <basicUdiDi>B-A016CW</basicUdiDi>
    <tradeName>INDICAID™ Mycoplasma Pneumoniae (MP) Rapid Antigen Test</tradeName>
    <deviceName>INDICAID™ Mycoplasma Pneumoniae (MP) Rapid Antigen Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Mycoplasma Pneumoniae (MP) Rapid Antigen Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:14:23.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A015CU</udiDi>
    <basicUdiDi>B-A015CU</basicUdiDi>
    <tradeName>INDICAID™ Adenovirus Rapid Antigen Test</tradeName>
    <deviceName>INDICAID™ Adenovirus Rapid Antigen Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Adenovirus Rapid Antigen Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:14:22.236Z</lastUpdated>
  </row>
</eudamedExport>