<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08057723370202</udiDi>
    <basicUdiDi>B-08057723370202</basicUdiDi>
    <tradeName>08057723370202</tradeName>
    <deviceName>SensiQuant Direct PML/RARa MasterMix BCR3</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-045.3</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:36:09.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057723370196</udiDi>
    <basicUdiDi>B-08057723370196</basicUdiDi>
    <tradeName>08057723370196</tradeName>
    <deviceName>SensiQuant Direct PML/RARa MasterMix BCR2</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-045.2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:36:08.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057723370189</udiDi>
    <basicUdiDi>B-08057723370189</basicUdiDi>
    <tradeName>08057723370189</tradeName>
    <deviceName>SensiQuant Direct PML/RARa MasterMix BCR1</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-045.1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:36:07.722Z</lastUpdated>
  </row>
  <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>08057723370066</udiDi>
    <basicUdiDi>B-08057723370066</basicUdiDi>
    <tradeName>08057723370066</tradeName>
    <deviceName>PhilaREF</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060208</emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SRF-027</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:35:46.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057723370059</udiDi>
    <basicUdiDi>B-08057723370059</basicUdiDi>
    <tradeName>08057723370059</tradeName>
    <deviceName>SensiQuant P190 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>W01060208</emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SQT-028RG</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:35:46.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057723370042</udiDi>
    <basicUdiDi>B-08057723370042</basicUdiDi>
    <tradeName>08057723370042</tradeName>
    <deviceName>SensiQuant P190 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>W01060208</emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SQT-028</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:35:42.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057723370035</udiDi>
    <basicUdiDi>B-08057723370035</basicUdiDi>
    <tradeName>08057723370035</tradeName>
    <deviceName>SensiQuant P210 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>W01060208</emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SQT-027RG</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:35:41.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057723370028</udiDi>
    <basicUdiDi>B-08057723370028</basicUdiDi>
    <tradeName>08057723370028</tradeName>
    <deviceName>SensiQuant P210 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>W01060208</emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SQT-027</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:35:40.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057723370011</udiDi>
    <basicUdiDi>B-08057723370011</basicUdiDi>
    <tradeName>08057723370011</tradeName>
    <deviceName>SensiQuant P190 Standard</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060208</emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STD-028</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:35:39.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057723370004</udiDi>
    <basicUdiDi>B-08057723370004</basicUdiDi>
    <tradeName>08057723370004</tradeName>
    <deviceName>SensiQuant P210 Standard</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060208</emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STD-027</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:35:34.903Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350040631775</udiDi>
    <basicUdiDi>B-07350040631775</basicUdiDi>
    <tradeName>Devyser BRCA</tradeName>
    <deviceName>Devyser BRCA</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060203</emdnCode>
    <emdnDescription>BRCA 1+2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A100-24</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:59.658Z</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>07350040631270</udiDi>
    <basicUdiDi>B-07350040631270</basicUdiDi>
    <tradeName>Devyser BRCA</tradeName>
    <deviceName>Devyser BRCA</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060203</emdnCode>
    <emdnDescription>BRCA 1+2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A100-96</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:37.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350040631263</udiDi>
    <basicUdiDi>B-07350040631263</basicUdiDi>
    <tradeName>Devyser BRCA</tradeName>
    <deviceName>Devyser BRCA</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060203</emdnCode>
    <emdnDescription>BRCA 1+2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A100-8</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:37.190Z</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>
</eudamedExport>