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<eudamedExport entity="devices">
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    <udiDi>05055844906518</udiDi>
    <basicUdiDi>50558449LPH038JQ</basicUdiDi>
    <tradeName>BCR/ABL (ABL1) Plus Translocation, Dual Fusion Probe</tradeName>
    <deviceName>BCR/ABL (ABL1) Plus Translocation, Dual Fusion Probe</deviceName>
    <manufacturerName>Cytocell Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000016893</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01060208</emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 038-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:18:21.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844906181</udiDi>
    <basicUdiDi>50558449LPH007JD</basicUdiDi>
    <tradeName>BCR/ABL (ABL1) Translocation, Dual Fusion Probe</tradeName>
    <deviceName>BCR/ABL (ABL1) Translocation, Dual Fusion Probe</deviceName>
    <manufacturerName>Cytocell Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000016893</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01060208</emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:18:06.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251315812239</udiDi>
    <basicUdiDi>42513158D-5082IVDL2</basicUdiDi>
    <tradeName>XL BCR/ABL1/ASS</tradeName>
    <deviceName>XL BCR/ABL1/ASS</deviceName>
    <manufacturerName>MetaSystems Probes GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006315</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01060208</emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-5082-100-TC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:58:07.174Z</lastUpdated>
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  <row>
    <udiDi>04251315812093</udiDi>
    <basicUdiDi>42513158D-5052IVDJZ</basicUdiDi>
    <tradeName>XL BCR/ABL1 plus</tradeName>
    <deviceName>XL BCR/ABL1 plus</deviceName>
    <manufacturerName>MetaSystems Probes GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006315</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01060208</emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-5052-100-OG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:57:43.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405BCRSCRRTF7</udiDi>
    <basicUdiDi>B-TRMF000028405BCRSCRRTF7</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP BCR-ABL1 (p190, p210, p230) Screening Kit, 48T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060208</emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCRSCR-RT48</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:20:50.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405BCR230RTTN</udiDi>
    <basicUdiDi>B-TRMF000028405BCR230RTTN</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP BCR-ABL1 p230(μbcr) Detection Kit, 48T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060208</emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCR230-RT48</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:20:49.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405BCR210RTT8</udiDi>
    <basicUdiDi>B-TRMF000028405BCR210RTT8</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP BCR-ABL1 p210(Mbcr) IS-MMR Detection Kit, 48T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060208</emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCR210-RT48</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:20:48.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405BCR190RTUM</udiDi>
    <basicUdiDi>B-TRMF000028405BCR190RTUM</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP BCR-ABL1 p190(mbcr) Detection Kit, 48T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060208</emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCR190-RT48</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:20:47.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809740940087</udiDi>
    <basicUdiDi>B-08809740940087</basicUdiDi>
    <tradeName>Dr. PCR™ BCR-ABL1 Major IS Detection Kit</tradeName>
    <deviceName>Dr. PCR™ BCR-ABL1 Major IS Detection Kit</deviceName>
    <manufacturerName>OPTOLANE Technologies Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000026042</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060208</emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DON01-X</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T13:40:50.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057723370554</udiDi>
    <basicUdiDi>B-08057723370554</basicUdiDi>
    <tradeName>08057723370554</tradeName>
    <deviceName>Lyoset P190 Reference</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>LRF-028</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:37:20.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057723370547</udiDi>
    <basicUdiDi>B-08057723370547</basicUdiDi>
    <tradeName>08057723370547</tradeName>
    <deviceName>Lyoset P210 Reference</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>LRF-027</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:37:19.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057723370530</udiDi>
    <basicUdiDi>B-08057723370530</basicUdiDi>
    <tradeName>08057723370530</tradeName>
    <deviceName>SensiQuant P230 Positive Control</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>CTRL-040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:37:19.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057723370523</udiDi>
    <basicUdiDi>B-08057723370523</basicUdiDi>
    <tradeName>08057723370523</tradeName>
    <deviceName>SensiQuant P230 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-040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:37:18.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057723370516</udiDi>
    <basicUdiDi>B-08057723370516</basicUdiDi>
    <tradeName>08057723370516</tradeName>
    <deviceName>SensiQuant Direct P230 Master Mix</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>SQTd-040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:37:14.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057723370448</udiDi>
    <basicUdiDi>B-08057723370448</basicUdiDi>
    <tradeName>08057723370448</tradeName>
    <deviceName>SensiQuant P190 Positive Control</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>CTRL-028</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:37:04.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057723370431</udiDi>
    <basicUdiDi>B-08057723370431</basicUdiDi>
    <tradeName>08057723370431</tradeName>
    <deviceName>SensiQuant Direct 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>SQTd-028</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:37:00.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057723370424</udiDi>
    <basicUdiDi>B-08057723370424</basicUdiDi>
    <tradeName>08057723370424</tradeName>
    <deviceName>SensiQuant P210 Positive Control</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>CTRL-027</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:36:59.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057723370417</udiDi>
    <basicUdiDi>B-08057723370417</basicUdiDi>
    <tradeName>08057723370417</tradeName>
    <deviceName>SensiQuant Direct 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>SQTd-027</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:36:59.005Z</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>
</eudamedExport>