<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08057723370172</udiDi>
    <basicUdiDi>B-08057723370172</basicUdiDi>
    <tradeName>08057723370172</tradeName>
    <deviceName>SensiQuant Direct PML/RARa MasterMix</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SQTd-045</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:36:07.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057723370165</udiDi>
    <basicUdiDi>B-08057723370165</basicUdiDi>
    <tradeName>08057723370165</tradeName>
    <deviceName>SensiQuant Direct ABL MasterMix</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SQTd-033S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:36:02.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057723370158</udiDi>
    <basicUdiDi>B-08057723370158</basicUdiDi>
    <tradeName>08057723370158</tradeName>
    <deviceName>SensiQuant Direct ABL MasterMix</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SQTd-033</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:36:01.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350040631638</udiDi>
    <basicUdiDi>B-07350040631638</basicUdiDi>
    <tradeName>Devyser HBOC</tradeName>
    <deviceName>Devyser HBOC</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A111-24</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:58.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350040631645</udiDi>
    <basicUdiDi>B-07350040631645</basicUdiDi>
    <tradeName>Devyser HBOC</tradeName>
    <deviceName>Devyser HBOC</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A111-48</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:57.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350040630761</udiDi>
    <basicUdiDi>B-07350040630761</basicUdiDi>
    <tradeName>Devyser HFE v2</tradeName>
    <deviceName>Devyser HFE v2</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A030.2</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:32.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350040630273</udiDi>
    <basicUdiDi>B-07350040630273</basicUdiDi>
    <tradeName>Devyser AZF v2</tradeName>
    <deviceName>Devyser AZF v2</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A019.2</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:01.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350040630297</udiDi>
    <basicUdiDi>B-07350040630297</basicUdiDi>
    <tradeName>Devyser AZF Extension</tradeName>
    <deviceName>Devyser AZF Extension</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A020</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:12:59.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332940007898</udiDi>
    <basicUdiDi>B-07332940007898</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® BCR-ABL Ultra p190</deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXBCRABLP190-CE-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:06:20.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332940001834</udiDi>
    <basicUdiDi>B-07332940001834</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXBCRABL-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:06:19.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977334213090</udiDi>
    <basicUdiDi>B-06977334213090</basicUdiDi>
    <tradeName>Solid Tumor Multi-gene Combined Detection Kit ( Reversible Terminator Sequencing)</tradeName>
    <deviceName>Solid Tumor Multi-gene Combined Detection Kit ( Reversible Terminator Sequencing)</deviceName>
    <manufacturerName>Shanghai YJMED BioTechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055692</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>96 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:17:30.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977334213083</udiDi>
    <basicUdiDi>B-06977334213083</basicUdiDi>
    <tradeName>06977334213083</tradeName>
    <deviceName>Solid Tumor Multi-gene Combined Detection Kit (Reversible Terminator Sequencing)</deviceName>
    <manufacturerName>Shanghai YJMED BioTechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055692</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:17:29.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976043630174</udiDi>
    <basicUdiDi>B-06976043630174</basicUdiDi>
    <tradeName>06976043630174</tradeName>
    <deviceName>Lung Cancer Associated Gene Methylation Detection Kit</deviceName>
    <manufacturerName>iCarbonX IntelliCore (Guangdong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045482</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>017</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:27:08.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976043630143</udiDi>
    <basicUdiDi>B-06976043630143</basicUdiDi>
    <tradeName>06976043630143</tradeName>
    <deviceName>Human 10-Gene Mutation Detection Kit</deviceName>
    <manufacturerName>iCarbonX IntelliCore (Guangdong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045482</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>014</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:26:52.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975977070605</udiDi>
    <basicUdiDi>B-06975977070605</basicUdiDi>
    <tradeName>06975977070605</tradeName>
    <deviceName>BRAF V600E/D/R/K Mutations  Detection Kit （Multiplex  Real-time PCR）</deviceName>
    <manufacturerName>Gold Probe Diagnostic Biotechnology Inc. MF</manufacturerName>
    <manufacturerSrn>CN-MF-000031524</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>600060</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:16:32.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975977070506</udiDi>
    <basicUdiDi>B-06975977070506</basicUdiDi>
    <tradeName>06975977070506</tradeName>
    <deviceName>Lung Cancer Mutant Genes  Detction Panel (Multiplex  Real-time PCR)</deviceName>
    <manufacturerName>Gold Probe Diagnostic Biotechnology Inc. MF</manufacturerName>
    <manufacturerSrn>CN-MF-000031524</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>600050</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:16:32.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975977070308</udiDi>
    <basicUdiDi>B-06975977070308</basicUdiDi>
    <tradeName>06975977070308</tradeName>
    <deviceName>TERT Promoter Mutation  Detection Kit（Real-time  PCR Assays）</deviceName>
    <manufacturerName>Gold Probe Diagnostic Biotechnology Inc. MF</manufacturerName>
    <manufacturerSrn>CN-MF-000031524</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>600030</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:16:28.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975977070209</udiDi>
    <basicUdiDi>B-06975977070209</basicUdiDi>
    <tradeName>06975977070209</tradeName>
    <deviceName>IDH1/IDH2 Gene Mutation  Detection Kit</deviceName>
    <manufacturerName>Gold Probe Diagnostic Biotechnology Inc. MF</manufacturerName>
    <manufacturerSrn>CN-MF-000031524</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>600020</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:16:27.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975970650033</udiDi>
    <basicUdiDi>B-06975970650033</basicUdiDi>
    <tradeName>Multi-Gene Methylation Detection Kit for Human Liver Cancer (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Multi-Gene Methylation Detection Kit for Human Liver Cancer (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>SINGLERA GENOMICS (JIANGSU) LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000033428</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QP02004802</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:16:25.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975760470186</udiDi>
    <basicUdiDi>B-06975760470186</basicUdiDi>
    <tradeName>PIK3CA 11 Mutations Digital PCR Assay</tradeName>
    <deviceName>PIK3CA 11 Mutations Digital PCR Assay</deviceName>
    <manufacturerName>Suzhou Precigenome Ltd, Co;</manufacturerName>
    <manufacturerSrn>CN-MF-000024105</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.02.03.0005</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:11:22.111Z</lastUpdated>
  </row>
</eudamedExport>