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    <basicUdiDi>50558449LPH022J9</basicUdiDi>
    <tradeName>CBFß (CBFB)/MYH11 Translocation, Dual Fusion Probe</tradeName>
    <deviceName>CBFß (CBFB)/MYH11 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>W01060211</emdnCode>
    <emdnDescription>INV (16)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:18:12.571Z</lastUpdated>
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  <row>
    <udiDi>D-TRMF000028405CBFRT24BJ</udiDi>
    <basicUdiDi>B-TRMF000028405CBFRT24BJ</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP CBFB-MYH11 Inv(16) Detection Kit, 24T</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>W01060211</emdnCode>
    <emdnDescription>INV (16)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CBF-RT24</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:20:54.972Z</lastUpdated>
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  <row>
    <udiDi>08057723370400</udiDi>
    <basicUdiDi>B-08057723370400</basicUdiDi>
    <tradeName>08057723370400</tradeName>
    <deviceName>SensiQuant CBFB/MYH11 Positive Control INV-16E</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060211</emdnCode>
    <emdnDescription>INV (16)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTRL-046.E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:36:58.205Z</lastUpdated>
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    <udiDi>08057723370394</udiDi>
    <basicUdiDi>B-08057723370394</basicUdiDi>
    <tradeName>08057723370394</tradeName>
    <deviceName>SensiQuant CBFB/MYH11 Positive Control INV-16D</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060211</emdnCode>
    <emdnDescription>INV (16)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTRL-046.D</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:36:54.203Z</lastUpdated>
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    <udiDi>08057723370387</udiDi>
    <basicUdiDi>B-08057723370387</basicUdiDi>
    <tradeName>08057723370387</tradeName>
    <deviceName>SensiQuant CBFB/MYH11 Positive Control INV-16A</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060211</emdnCode>
    <emdnDescription>INV (16)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTRL-046.A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:36:53.396Z</lastUpdated>
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  <row>
    <udiDi>08057723370370</udiDi>
    <basicUdiDi>B-08057723370370</basicUdiDi>
    <tradeName>08057723370370</tradeName>
    <deviceName>SensiQuant CBFB/MYH11 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>W01060211</emdnCode>
    <emdnDescription>INV (16)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTRL-046</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:36:52.596Z</lastUpdated>
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  <row>
    <udiDi>08057723370363</udiDi>
    <basicUdiDi>B-08057723370363</basicUdiDi>
    <tradeName>08057723370363</tradeName>
    <deviceName>SensiQuant CBFB/MYH11 Standard INV-16E</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060211</emdnCode>
    <emdnDescription>INV (16)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STD-046.E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:36:51.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057723370356</udiDi>
    <basicUdiDi>B-08057723370356</basicUdiDi>
    <tradeName>08057723370356</tradeName>
    <deviceName>SensiQuant CBFB/MYH11 Standard INV-16D</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060211</emdnCode>
    <emdnDescription>INV (16)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STD-046.D</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:36:34.945Z</lastUpdated>
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  <row>
    <udiDi>08057723370349</udiDi>
    <basicUdiDi>B-08057723370349</basicUdiDi>
    <tradeName>08057723370349</tradeName>
    <deviceName>SensiQuant CBFB/MYH11 Standard INV-16A</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060211</emdnCode>
    <emdnDescription>INV (16)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STD-046.A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:36:34.142Z</lastUpdated>
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    <udiDi>08057723370332</udiDi>
    <basicUdiDi>B-08057723370332</basicUdiDi>
    <tradeName>08057723370332</tradeName>
    <deviceName>SensiQuant CBFB/MYH11 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>W01060211</emdnCode>
    <emdnDescription>INV (16)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STD-046</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:36:33.342Z</lastUpdated>
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  <row>
    <udiDi>08057723370325</udiDi>
    <basicUdiDi>B-08057723370325</basicUdiDi>
    <tradeName>08057723370325</tradeName>
    <deviceName>SensiQuant Direct CBFB/MYH11 MasterMix INV-16E</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060211</emdnCode>
    <emdnDescription>INV (16)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SQTd-046.E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:36:29.348Z</lastUpdated>
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    <udiDi>08057723370318</udiDi>
    <basicUdiDi>B-08057723370318</basicUdiDi>
    <tradeName>08057723370318</tradeName>
    <deviceName>SensiQuant Direct CBFB/MYH11 MasterMix INV-16D</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060211</emdnCode>
    <emdnDescription>INV (16)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SQTd-046.D</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:36:28.551Z</lastUpdated>
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    <udiDi>08057723370301</udiDi>
    <basicUdiDi>B-08057723370301</basicUdiDi>
    <tradeName>08057723370301</tradeName>
    <deviceName>SensiQuant Direct CBFB/MYH11 MasterMix INV-16A</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060211</emdnCode>
    <emdnDescription>INV (16)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SQTd-046.A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:36:27.753Z</lastUpdated>
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  <row>
    <udiDi>08057723370295</udiDi>
    <basicUdiDi>B-08057723370295</basicUdiDi>
    <tradeName>08057723370295</tradeName>
    <deviceName>SensiQuant Direct CBFB/MYH11 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>W01060211</emdnCode>
    <emdnDescription>INV (16)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SQTd-046</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:36:26.939Z</lastUpdated>
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  <row>
    <udiDi>05055844906358</udiDi>
    <basicUdiDi>50558449LPH022J9</basicUdiDi>
    <tradeName>CBFß (CBFB)/MYH11 Translocation, Dual Fusion Probe</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W01060211</emdnCode>
    <emdnDescription>INV (16)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 022-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:56.774Z</lastUpdated>
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    <udiDi>05055844923591</udiDi>
    <basicUdiDi>50558449LPH022J9</basicUdiDi>
    <tradeName>CBFß (CBFB)/MYH11 Translocation, Dual Fusion Probe</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W01060211</emdnCode>
    <emdnDescription>INV (16)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:56.165Z</lastUpdated>
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    <udiDi>05055844923607</udiDi>
    <basicUdiDi>50558449LPH022J9</basicUdiDi>
    <tradeName>CBFß (CBFB)/MYH11 Translocation, Dual Fusion Probe</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W01060211</emdnCode>
    <emdnDescription>INV (16)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 022-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:56.148Z</lastUpdated>
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