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    <deviceName>SensiQuant PML/RARa 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>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STD-045</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:36:13.319Z</lastUpdated>
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    <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>
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    <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>
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    <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>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <udiDi>08057723370141</udiDi>
    <basicUdiDi>B-08057723370141</basicUdiDi>
    <tradeName>08057723370141</tradeName>
    <deviceName>SensiQuant SARS-CoV-2 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>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STD-044</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:36:00.517Z</lastUpdated>
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    <udiDi>08057723370134</udiDi>
    <basicUdiDi>B-08057723370134</basicUdiDi>
    <tradeName>08057723370134</tradeName>
    <deviceName>SensiQuant SARS-CoV-2 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>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SQT-044</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:35:59.718Z</lastUpdated>
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    <udiDi>08057723370127</udiDi>
    <basicUdiDi>B-08057723370127</basicUdiDi>
    <tradeName>08057723370127</tradeName>
    <deviceName>Plate PCR AMP</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0503010204</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC DISHES FOR MICROTECHNIQUES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL10126</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:35:55.728Z</lastUpdated>
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    <udiDi>08057723370110</udiDi>
    <basicUdiDi>B-08057723370110</basicUdiDi>
    <tradeName>08057723370110</tradeName>
    <deviceName>SMART SNP FII FVL Direct Kit</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010115</emdnCode>
    <emdnDescription>COMBINED FACTOR II / FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SNPD-034</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:35:54.927Z</lastUpdated>
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    <udiDi>08057723370103</udiDi>
    <basicUdiDi>B-08057723370103</basicUdiDi>
    <tradeName>08057723370103</tradeName>
    <deviceName>SMART SNP MTHFR 677 Direct Kit</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SNPD-033</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:35:54.255Z</lastUpdated>
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    <udiDi>08057723370097</udiDi>
    <basicUdiDi>B-08057723370097</basicUdiDi>
    <tradeName>08057723370097</tradeName>
    <deviceName>SMART SNP MTHFR 1298 Direct Kit</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SNPD-032</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:35:53.309Z</lastUpdated>
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    <udiDi>08057723370080</udiDi>
    <basicUdiDi>B-08057723370080</basicUdiDi>
    <tradeName>08057723370080</tradeName>
    <deviceName>SMART SNP FVL Direct Kit</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SNPD-030</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:35:48.512Z</lastUpdated>
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    <udiDi>08057723370073</udiDi>
    <basicUdiDi>B-08057723370073</basicUdiDi>
    <tradeName>08057723370073</tradeName>
    <deviceName>SMART SNP FII Direct Kit</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010114</emdnCode>
    <emdnDescription>PROTHROMBIN MUTATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SNPD-029</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:35:47.711Z</lastUpdated>
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    <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>
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    <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>
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    <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>
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    <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>
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    <basicUdiDi>B-08057723370035</basicUdiDi>
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    <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>
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    <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>
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