<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-G2M803221F7</udiDi>
    <basicUdiDi>B-G2M803221F7</basicUdiDi>
    <tradeName>SCA-Q Real Time PCR Kit (Sickle Cell Anemia)</tradeName>
    <deviceName>SCA-Q Real Time PCR Kit (Sickle Cell Anemia)</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010109</emdnCode>
    <emdnDescription>SICKLE CELL ANEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M803221,G2M803221R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:45:07.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2M803021EV</udiDi>
    <basicUdiDi>B-G2M803021EV</basicUdiDi>
    <tradeName>YCM-Q Real Time PCR Kit (Y Chromosome Microdeletion)</tradeName>
    <deviceName>YCM-Q Real Time PCR Kit (Y Chromosome Microdeletion)</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M803021,G2M803021R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:44:51.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2M801121EL</udiDi>
    <basicUdiDi>B-G2M801121EL</basicUdiDi>
    <tradeName>HLA B27-Q Real Time PCR Kit</tradeName>
    <deviceName>HLA B27-Q Real Time PCR Kit</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M801121, G2M801121R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:44:33.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CY-MF-0000093819M</udiDi>
    <basicUdiDi>B-CY-MF-0000093819M</basicUdiDi>
    <tradeName>VERACITY &amp; VERACITY HC IVD kit reagents and VEGA software</tradeName>
    <deviceName>VERACITY IVD KIT REAGENTS for 48 samples</deviceName>
    <manufacturerName>MEDICOVER GENETICS LIMITED</manufacturerName>
    <manufacturerSrn>CY-MF-000009381</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010301</emdnCode>
    <emdnDescription>DOWN'S SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV100-00-248</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-13T10:39:30.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000049232R3300196W9</udiDi>
    <basicUdiDi>B-CNMF000049232R3300196W9</basicUdiDi>
    <tradeName>Human Survival Motor Neuron(SMN)Gene Detection Kit (Digital PCR Method)</tradeName>
    <deviceName>Human Survival Motor Neuron(SMN)Gene Detection Kit (Digital PCR Method)</deviceName>
    <manufacturerName>Shenzhen Biorain biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049232</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R33001-096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:07:09.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000049232R3300148VW</udiDi>
    <basicUdiDi>B-CNMF000049232R3300148VW</basicUdiDi>
    <tradeName>Human Survival Motor Neuron(SMN)Gene Detection Kit (Digital PCR Method)</tradeName>
    <deviceName>Human Survival Motor Neuron(SMN)Gene Detection Kit (Digital PCR Method)</deviceName>
    <manufacturerName>Shenzhen Biorain biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049232</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R33001-048</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:07:08.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-9021B6</udiDi>
    <basicUdiDi>B-9021B6</basicUdiDi>
    <tradeName>D-9021B6</tradeName>
    <deviceName>Partner and Localiser of BRCA2 (PALB2) Library Prep Kit for Illumina®</deviceName>
    <manufacturerName>NimaGen BV</manufacturerName>
    <manufacturerSrn>NL-MF-000022926</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RC-PALB096-I</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:55:05.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-9018BH</udiDi>
    <basicUdiDi>B-9018BH</basicUdiDi>
    <tradeName>D-9018BH</tradeName>
    <deviceName>Cystic Fibrosis Transmembrane Conductance Regulator Gene (CFTR) Library Prep Kit for Illumina®</deviceName>
    <manufacturerName>NimaGen BV</manufacturerName>
    <manufacturerSrn>NL-MF-000022926</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RC-CFTR096-I</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:55:00.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-9017BF</udiDi>
    <basicUdiDi>B-9017BF</basicUdiDi>
    <tradeName>D-9017BF</tradeName>
    <deviceName>Cystic Fibrosis Transmembrane Conductance Regulator Gene (CFTR) Mutation Hotspots Library Prep Kit for Illumina®</deviceName>
    <manufacturerName>NimaGen BV</manufacturerName>
    <manufacturerSrn>NL-MF-000022926</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RC-CFHS096-I</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:54:55.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-90085-RTFE</udiDi>
    <basicUdiDi>B-90085-RTFE</basicUdiDi>
    <tradeName>D-90085-RTFE</tradeName>
    <deviceName>EliGene® CELIAC DQ PLUS RT</deviceName>
    <manufacturerName>ELISABETH PHARMACON, spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000025244</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90085-RT</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:54:36.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-90071-RTE7</udiDi>
    <basicUdiDi>B-90071-RTE7</basicUdiDi>
    <tradeName>D-90071-RTE7</tradeName>
    <deviceName>EliGene® Coeliac 3.0 RT</deviceName>
    <manufacturerName>ELISABETH PHARMACON, spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000025244</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90071-RT</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:54:35.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-86804222814035R</udiDi>
    <basicUdiDi>B-86804222814035R</basicUdiDi>
    <tradeName>IntRaFast-Q SMA SCREENING KIT</tradeName>
    <deviceName>IntRaFast-Q SMA SCREENING KIT</deviceName>
    <manufacturerName>SNP BİYOTEKNOLOJİ ARAŞTIRMA GELİŞTİRME VE ÜRETİM SANAYİ VE TİCARET LİMİTED ŞİRKETİLİMİTED</manufacturerName>
    <manufacturerSrn>TR-MF-000036548</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200R-40-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T08:18:27.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-84295773154WTGK</udiDi>
    <basicUdiDi>B-84295773154WTGK</basicUdiDi>
    <tradeName>HLA B27 Strip</tradeName>
    <deviceName>HLA B27 Strip</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.154.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:30.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-84295773152WPFZ</udiDi>
    <basicUdiDi>B-84295773152WPFZ</basicUdiDi>
    <tradeName>CeliacStrip</tradeName>
    <deviceName>CeliacStrip</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.152.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:29.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-84295773151WMFN</udiDi>
    <basicUdiDi>B-84295773151WMFN</basicUdiDi>
    <tradeName>YChromStrip</tradeName>
    <deviceName>YChromStrip</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.151.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:26.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-84295773135WPG2</udiDi>
    <basicUdiDi>B-84295773135WPG2</basicUdiDi>
    <tradeName>LactoStrip</tradeName>
    <deviceName>LactoStrip</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010402</emdnCode>
    <emdnDescription>LACTOSE INTOLERANCE (POLYMORPHISMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.135.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:20.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-84295773130WDEH</udiDi>
    <basicUdiDi>B-84295773130WDEH</basicUdiDi>
    <tradeName>HemochromaStrip</tradeName>
    <deviceName>HemochromaStrip</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010105</emdnCode>
    <emdnDescription>HAEMOCHROMATOSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.130.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:18.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-84295773117WMFQ</udiDi>
    <basicUdiDi>B-84295773117WMFQ</basicUdiDi>
    <tradeName>ThromboSrip</tradeName>
    <deviceName>ThromboStrip</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010115</emdnCode>
    <emdnDescription>COMBINED FACTOR II / FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.117.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:18.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>09120110506405</udiDi>
    <basicUdiDi>912011050HUFGRXX8D</basicUdiDi>
    <tradeName>FetoGnost® Kit RHD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ingenetix GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000001501</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf D</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HUFG500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:57:35.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>19358706000106</udiDi>
    <basicUdiDi>B-19358706000106</basicUdiDi>
    <tradeName>19358706000106</tradeName>
    <deviceName>AlloSeq HCT</deviceName>
    <manufacturerName>CareDx Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000046711</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASHCT.1(96)-IVD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:12:05.662Z</lastUpdated>
  </row>
</eudamedExport>