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<eudamedExport entity="devices">
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    <udiDi>08697962617340</udiDi>
    <basicUdiDi>B-08697962617340</basicUdiDi>
    <tradeName>IND ONE STEP HCG RAPID PREGNANCY TEST</tradeName>
    <deviceName>ONE STEP HCG RAPID PREGNANCY TEST</deviceName>
    <manufacturerName>ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000046897</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFTHCG-M</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:22:26.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>08697962616732</udiDi>
    <basicUdiDi>B-08697962616732</basicUdiDi>
    <tradeName>SOFTEC Dengue NS1 Rapid Test Kit</tradeName>
    <deviceName>Dengue NS1 Rapid Test Kit</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>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFDNNS1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:22:25.656Z</lastUpdated>
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    <udiDi>08697962616725</udiDi>
    <basicUdiDi>B-08697962616725</basicUdiDi>
    <tradeName>SOFTEC Dengue NS1/IgG/IgM Combo Rapid Test Kit</tradeName>
    <deviceName>Dengue NS1/IgG/IgM Combo Rapid Test Kit</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>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFDNCB</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:22:07.195Z</lastUpdated>
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    <udiDi>08697962616718</udiDi>
    <basicUdiDi>B-08697962616718</basicUdiDi>
    <tradeName>SOFTEC Malaria P.f/P.v Rapid Test Kit</tradeName>
    <deviceName>Malaria P.f/P.v Rapid Test Kit</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>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFMPFPV</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:22:06.390Z</lastUpdated>
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  <row>
    <udiDi>08697962616596</udiDi>
    <basicUdiDi>B-08697962616596</basicUdiDi>
    <tradeName>SOFTEC Human Papillomavirus (HPV) High Risk Panel Qualitative RT-qPCR Detection Kit</tradeName>
    <deviceName>Human Papillomavirus (HPV) High Risk Panel Qualitative RT-qPCR Detection Kit</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>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZT-HPV-01-100</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:22:05.592Z</lastUpdated>
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  <row>
    <udiDi>08697962616541</udiDi>
    <basicUdiDi>B-08697962616541</basicUdiDi>
    <tradeName>SOFTEC Herpes Simplex Virus (HSV-1 &amp; HSV-2) Qualitative RT-qPCR Detection Kit</tradeName>
    <deviceName>Herpes Simplex Virus (HSV-1 &amp; HSV-2) Qualitative RT-qPCR Detection Kit</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>W0105040399</emdnCode>
    <emdnDescription>HSV REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZT-HSV-01-100</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:22:04.789Z</lastUpdated>
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  <row>
    <udiDi>08697962616527</udiDi>
    <basicUdiDi>B-08697962616527</basicUdiDi>
    <tradeName>BEBE TIME PREGNANCY TEST</tradeName>
    <deviceName>Pregnancy Test</deviceName>
    <manufacturerName>ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000046897</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STRİP</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:22:00.787Z</lastUpdated>
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  <row>
    <udiDi>08697962616374</udiDi>
    <basicUdiDi>B-08697962616374</basicUdiDi>
    <tradeName>BIG KIT One Step Human Chorionic Gonadotropin (hCG) Pregnancy Test</tradeName>
    <deviceName>One Step Human Chorionic Gonadotropin (hCG) Pregnancy Test</deviceName>
    <manufacturerName>ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000046897</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BKHCG</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:22:00.004Z</lastUpdated>
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  <row>
    <udiDi>08697962616367</udiDi>
    <basicUdiDi>B-08697962616367</basicUdiDi>
    <tradeName>BEBE TIME PREGNANCY TEST</tradeName>
    <deviceName>PREGNANCY 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BEBE TIME</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:21:59.189Z</lastUpdated>
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  <row>
    <udiDi>08697962616350</udiDi>
    <basicUdiDi>B-08697962616350</basicUdiDi>
    <tradeName>SOFTEC Syphilis Rapid Test Kit (Cassette)</tradeName>
    <deviceName>Syphilis Rapid Test Kit (Cassette)</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>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFSPRT</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:21:58.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>08697962616343</udiDi>
    <basicUdiDi>B-08697962616343</basicUdiDi>
    <tradeName>SOFTEC Magic-Auto Whole Blood DNA/RNA Isolation Kit</tradeName>
    <deviceName>Magic-Auto Whole Blood DNA/RNA Isolation Kit</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>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZT-MAWB-01-96</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:21:54.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>08697962616312</udiDi>
    <basicUdiDi>B-08697962616312</basicUdiDi>
    <tradeName>SOFTEC SARS-CoV-2 Antigen Rapid Test Kit (Nasal Swab)</tradeName>
    <deviceName>SARS-CoV-2 Antigen Rapid Test Kit (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>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZET01N</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:21:53.579Z</lastUpdated>
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  <row>
    <udiDi>08697962616305</udiDi>
    <basicUdiDi>B-08697962616305</basicUdiDi>
    <tradeName>SOFTEC Tuberculosis Rapid Test Kit</tradeName>
    <deviceName>Tuberculosis Rapid Test Kit</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>W0105010702</emdnCode>
    <emdnDescription>MYCOBACTERIAL ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFTB</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:21:52.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>08697962616299</udiDi>
    <basicUdiDi>B-08697962616299</basicUdiDi>
    <tradeName>SOFTEC Creatine Kinase-MB Rapid Test Kit</tradeName>
    <deviceName>CK-MB Rapid Test Kit</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>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFCKMB</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:21:51.984Z</lastUpdated>
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  <row>
    <udiDi>08697962616282</udiDi>
    <basicUdiDi>B-08697962616282</basicUdiDi>
    <tradeName>SOFTEC Hepatitis E Virus (HEV) IgG/IgM Rapid Test Kit</tradeName>
    <deviceName>Hepatitis E Virus (HEV) IgG/IgM Rapid Test Kit</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>W0105020503</emdnCode>
    <emdnDescription>HEV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFHEV</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:21:47.987Z</lastUpdated>
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    <udiDi>08697962616275</udiDi>
    <basicUdiDi>B-08697962616275</basicUdiDi>
    <tradeName>SOFTEC Troponin I Rapid Test Kit</tradeName>
    <deviceName>Troponin I Rapid Test Kit</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>W0102160703</emdnCode>
    <emdnDescription>TROPONIN I/T - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFTPI</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:21:47.195Z</lastUpdated>
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    <udiDi>08697962616268</udiDi>
    <basicUdiDi>B-08697962616268</basicUdiDi>
    <tradeName>SOFTEC H.Pylori Antigen test</tradeName>
    <deviceName>SOFTEC H.Pylori Antigen 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>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFTHPAG</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:21:46.383Z</lastUpdated>
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    <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>
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  <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>
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    <udiDi>08697962616190</udiDi>
    <basicUdiDi>B-08697962616190</basicUdiDi>
    <tradeName>SOFTEC LH Ovulation Rapid Test Midstream</tradeName>
    <deviceName>LH Ovulation Rapid Test Midstream</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>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFTLH-M</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:21:40.780Z</lastUpdated>
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