<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>D-A004CP</udiDi>
    <basicUdiDi>B-A004CP</basicUdiDi>
    <tradeName>D-A004CP</tradeName>
    <deviceName>INDICAID™ Covid-19/Flu A&amp;B 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>W0105090601</emdnCode>
    <emdnDescription>CORONAVIRUS / INFLUENZA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P0098</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:13:59.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>86979834610399</udiDi>
    <basicUdiDi>B-86979834610399</basicUdiDi>
    <tradeName>Vaginitis and Sexually Transmitted Infection Test  Device(Urogenital Swab/Serum/plasma/whole blood)</tradeName>
    <deviceName>Vaginitis and Sexually Transmitted Infection Test  Device(Urogenital Swab/Serum/plasma/whole blood)</deviceName>
    <manufacturerName>Neo-nostics (Suzhou) Bioengineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013087</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VAG0243</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T14:22:37.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>86979834610207</udiDi>
    <basicUdiDi>B-86979834610207</basicUdiDi>
    <tradeName>Respiratory Infection Test  Device(Nasal/Nasopharyngeal/Oropharyngeal/Serum/plasma/ whole blood)</tradeName>
    <deviceName>Respiratory Infection Test  Device(Nasal/Nasopharyngeal/Oropharyngeal/Serum/plasma/ whole blood)</deviceName>
    <manufacturerName>Neo-nostics (Suzhou) Bioengineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013087</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RES0242</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T14:22:18.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-84295779242Y3GZ</udiDi>
    <basicUdiDi>B-84295779242Y3GZ</basicUdiDi>
    <tradeName>Simple Ag SARS-CoV-2 / Flu A+B</tradeName>
    <deviceName>Simple Ag SARS-CoV-2 / Flu A+B</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090601</emdnCode>
    <emdnDescription>CORONAVIRUS / INFLUENZA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.242.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:09:17.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4680008050503VRG3</udiDi>
    <basicUdiDi>B-4680008050503VRG3</basicUdiDi>
    <tradeName>AMA DENT</tradeName>
    <deviceName>Enzymatic express-test for the microbe-associated periodontal disease (AMA DENT)</deviceName>
    <manufacturerName>«Association of Medicine and Analytics» Company Limited</manufacturerName>
    <manufacturerSrn>RU-MF-000036645</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>0503</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:54:08.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4680008050502VPFS</udiDi>
    <basicUdiDi>B-4680008050502VPFS</basicUdiDi>
    <tradeName>AMA VENERA</tradeName>
    <deviceName>Enzymatic express-test for the detection of mycoplasmosis and ureaplasmosis (AMA VENERA)</deviceName>
    <manufacturerName>«Association of Medicine and Analytics» Company Limited</manufacturerName>
    <manufacturerSrn>RU-MF-000036645</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>0502</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:54:05.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1N52C5YG</udiDi>
    <basicUdiDi>B-1N52C5YG</basicUdiDi>
    <tradeName>Rapid Flu A+B/RSV/ADV Antigen Test Card</tradeName>
    <deviceName>Rapid Flu A+B/RSV/ADV Antigen Test Card</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N52C5-1-EU, 1N52C5-20-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:17:41.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1N48C5Z7</udiDi>
    <basicUdiDi>B-1N48C5Z7</basicUdiDi>
    <tradeName>Rapid Flu A+B/RSV Antigen Test Card</tradeName>
    <deviceName>Rapid Flu A+B/RSV Antigen Test Card</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N48C5-1-EU, 1N48C5-20-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:17:40.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>16952804833715</udiDi>
    <basicUdiDi>B-16952804833715</basicUdiDi>
    <tradeName>Fastep</tradeName>
    <deviceName>COVID-19 &amp; Influenza A/B Antigen Nasal Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090601</emdnCode>
    <emdnDescription>CORONAVIRUS / INFLUENZA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI-S33001H5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:07:51.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763150</udiDi>
    <basicUdiDi>B-15065023763150</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>Rotavirus/Adenovirus Combo Rapid Test (LFA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV10016</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:34:16.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763051</udiDi>
    <basicUdiDi>B-15065023763051</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>COVID-19&amp; Influenza A +B Antigen Combo Rapid Test (LFA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090601</emdnCode>
    <emdnDescription>CORONAVIRUS / INFLUENZA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV10006</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:34:01.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-098BC2X99</udiDi>
    <basicUdiDi>B-098BC2X99</basicUdiDi>
    <tradeName>COVID-19/FIu A&amp;B/RSV Ag Combo Rapid Test Cassette (Swab)</tradeName>
    <deviceName>COVID-19/FIu A&amp;B/RSV Ag Combo Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>Guangzhou Decheng Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013536</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090601</emdnCode>
    <emdnDescription>CORONAVIRUS / INFLUENZA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>098BC2X001, 098BC2X005, 098BC2X025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:32:48.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>08697962616213</udiDi>
    <basicUdiDi>B-08697962616213</basicUdiDi>
    <tradeName>SOFTEC SARS-CoV-2 Antigen Rapid Test (Nasal Swab)</tradeName>
    <deviceName>SARS-CoV-2 Antigen Rapid Test (Nasal Swab)</deviceName>
    <manufacturerName>ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000046897</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZET01N</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:21:45.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>08697962616206</udiDi>
    <basicUdiDi>B-08697962616206</basicUdiDi>
    <tradeName>SOFTEC SARS-CoV-2 Neutralizing Antibody Rapid Test</tradeName>
    <deviceName>SARS-CoV-2 Neutralizing Antibody Rapid Test</deviceName>
    <manufacturerName>ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000046897</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFTNAB-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:21:41.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>08697962616077</udiDi>
    <basicUdiDi>B-08697962616077</basicUdiDi>
    <tradeName>SARS-CoV-2 IgG/IgM Rapid Antibody Test</tradeName>
    <deviceName>SARS-CoV-2 IgG/IgM Rapid Antibody Test</deviceName>
    <manufacturerName>ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000046897</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFTCV</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:21:33.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>08693285188130</udiDi>
    <basicUdiDi>B-08693285188130</basicUdiDi>
    <tradeName>08693285188130</tradeName>
    <deviceName>Sars-CoV-2 + Flu A/B Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TISF01025</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:34:46.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>08693285188116</udiDi>
    <basicUdiDi>B-08693285188116</basicUdiDi>
    <tradeName>08693285188116</tradeName>
    <deviceName>Sars-CoV-2 + Flu A/B + RSV + ADV Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TISFRA01025</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:34:45.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>08693285188109</udiDi>
    <basicUdiDi>B-08693285188109</basicUdiDi>
    <tradeName>08693285188109</tradeName>
    <deviceName>Sars-CoV-2 + Flu A/B + RSV Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TISFR01025</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:34:44.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>08693285187669</udiDi>
    <basicUdiDi>B-08693285187669</basicUdiDi>
    <tradeName>08693285187669</tradeName>
    <deviceName>Rotavirus Adenovirus Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TIRA01001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:33:35.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>08693285187300</udiDi>
    <basicUdiDi>B-08693285187300</basicUdiDi>
    <tradeName>08693285187300</tradeName>
    <deviceName>Rotavirus Adenovirus Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TIRA01010</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:32:38.922Z</lastUpdated>
  </row>
</eudamedExport>