<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06970341680459</udiDi>
    <basicUdiDi>69703416803202027HS</basicUdiDi>
    <tradeName>ß-THALASSAEMIA &amp; HbA1c Reagent Kit (HPLC)</tradeName>
    <deviceName>ß-THALASSAEMIA &amp; HbA1c Reagent Kit (HPLC)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320201205</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:53:11.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760322820157</udiDi>
    <basicUdiDi>376032282CGENF2F5FW</basicUdiDi>
    <tradeName>ThromboGUARD FII FV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APPOLON BIOTECK</manufacturerName>
    <manufacturerSrn>FR-MF-000022234</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010115</emdnCode>
    <emdnDescription>COMBINED FACTOR II / FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:00:28.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792731097</udiDi>
    <basicUdiDi>B-06955792731097</basicUdiDi>
    <tradeName>06955792731097</tradeName>
    <deviceName>α-Thalassemia Gene Diagnostic Kit(gap-PCR)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S3045E</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:29:57.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996004541</udiDi>
    <basicUdiDi>B-06950996004541</basicUdiDi>
    <tradeName>Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)</tradeName>
    <deviceName>Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N7001B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:33:13.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996004534</udiDi>
    <basicUdiDi>B-06950996004534</basicUdiDi>
    <tradeName>Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)</tradeName>
    <deviceName>Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N7001A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:33:12.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906213930467</udiDi>
    <basicUdiDi>89080153043B247NM</basicUdiDi>
    <tradeName>TRUPCR® HLA B-27 Real-Time PCR Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B247</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:47:59.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906213930474</udiDi>
    <basicUdiDi>89080153043B247NM</basicUdiDi>
    <tradeName>TRUPCR® HLA B-27 Real-Time PCR Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B248</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:47:59.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906213930498</udiDi>
    <basicUdiDi>89080153043B1301KP</basicUdiDi>
    <tradeName>TRUPCR® Factor V Leiden Mutation (G1691A) Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1301</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:47:59.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906213930504</udiDi>
    <basicUdiDi>89080153043B1301KP</basicUdiDi>
    <tradeName>TRUPCR® Factor V Leiden Mutation (G1691A) Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:47:59.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906213930528</udiDi>
    <basicUdiDi>89080153043B1321KV</basicUdiDi>
    <tradeName>TRUPCR® Factor II Prothrombin Mutation (G20210A) Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1321</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:47:59.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906213930535</udiDi>
    <basicUdiDi>89080153043B1321KV</basicUdiDi>
    <tradeName>TRUPCR® Factor II Prothrombin Mutation (G20210A) Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1322</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:47:59.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906213930559</udiDi>
    <basicUdiDi>89080153043B1331KY</basicUdiDi>
    <tradeName>TRUPCR® MTHFR Mutation Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1331</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:47:59.106Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906213930566</udiDi>
    <basicUdiDi>89080153043B1331KY</basicUdiDi>
    <tradeName>TRUPCR® MTHFR Mutation Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1332</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:47:59.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>06430079584004</udiDi>
    <basicUdiDi>B-06430079584004</basicUdiDi>
    <tradeName>Blueprint Genetics Sanger Platform</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blueprint Genetics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000009837</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAN-400</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:01:20.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>06430079583007</udiDi>
    <basicUdiDi>B-06430079583007</basicUdiDi>
    <tradeName>Blueprint Genetics dPCR Platform</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blueprint Genetics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000009837</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DPC-300</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:01:18.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>06430079581089</udiDi>
    <basicUdiDi>B-06430079581089</basicUdiDi>
    <tradeName>Blueprint Genetics WES Platform – Variant Seq + mtDNA Variant Seq</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blueprint Genetics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000009837</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WES-108</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:01:17.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>06430079581072</udiDi>
    <basicUdiDi>B-06430079581072</basicUdiDi>
    <tradeName>Blueprint Genetics WES Platform – Variant Seq</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blueprint Genetics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000009837</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WES-107</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:01:15.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>06430079581065</udiDi>
    <basicUdiDi>B-06430079581065</basicUdiDi>
    <tradeName>Blueprint Genetics WES Platform – Other Family Seq + mtDNA Seq</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blueprint Genetics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000009837</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WES-106</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:01:13.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>06430079581058</udiDi>
    <basicUdiDi>B-06430079581058</basicUdiDi>
    <tradeName>Blueprint Genetics WES Platform – Family Seq + mtDNA Seq</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blueprint Genetics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000009837</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WES-105</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:01:12.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>06430079581041</udiDi>
    <basicUdiDi>B-06430079581041</basicUdiDi>
    <tradeName>Blueprint Genetics WES Platform – Proband + mtDNA Seq</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blueprint Genetics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000009837</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WES-104</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:01:09.933Z</lastUpdated>
  </row>
</eudamedExport>