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    <basicUdiDi>081646702QA0800004325VX</basicUdiDi>
    <tradeName>FastPack IP Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Qualigen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025168</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08000043-A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:26:41.748Z</lastUpdated>
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    <udiDi>00816467020327</udiDi>
    <basicUdiDi>B-00816467020327</basicUdiDi>
    <tradeName>00816467020327</tradeName>
    <deviceName>FastPack Total PSA Calibrator 25s Kit</deviceName>
    <manufacturerName>Qualigen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025168</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25000077</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:00:55.826Z</lastUpdated>
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    <udiDi>00816467020136</udiDi>
    <basicUdiDi>B-00816467020136</basicUdiDi>
    <tradeName>00816467020136</tradeName>
    <deviceName>FastPack Control Kit International</deviceName>
    <manufacturerName>Qualigen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025168</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050199</emdnCode>
    <emdnDescription>MULTICOMPONENT CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25000065</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:00:55.020Z</lastUpdated>
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    <udiDi>00816467020112</udiDi>
    <basicUdiDi>B-00816467020112</basicUdiDi>
    <tradeName>00816467020112</tradeName>
    <deviceName>FastPack hCG Diluent Kit</deviceName>
    <manufacturerName>Qualigen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025168</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25000036</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:00:54.035Z</lastUpdated>
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    <udiDi>00816467020105</udiDi>
    <basicUdiDi>B-00816467020105</basicUdiDi>
    <tradeName>00816467020105</tradeName>
    <deviceName>FastPack hCG Calibrator Kit</deviceName>
    <manufacturerName>Qualigen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025168</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152202</emdnCode>
    <emdnDescription>HORMONE STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25000035</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:00:52.444Z</lastUpdated>
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    <udiDi>00816467020099</udiDi>
    <basicUdiDi>B-00816467020099</basicUdiDi>
    <tradeName>00816467020099</tradeName>
    <deviceName>FastPack TSH Calibrator Kit</deviceName>
    <manufacturerName>Qualigen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025168</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152202</emdnCode>
    <emdnDescription>HORMONE STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25000024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:00:48.441Z</lastUpdated>
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    <udiDi>00816467020068</udiDi>
    <basicUdiDi>B-00816467020068</basicUdiDi>
    <tradeName>00816467020068</tradeName>
    <deviceName>FastPack FreeT4 Calibrator Kit</deviceName>
    <manufacturerName>Qualigen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025168</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152202</emdnCode>
    <emdnDescription>HORMONE STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25000016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:00:47.653Z</lastUpdated>
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    <udiDi>00816467020044</udiDi>
    <basicUdiDi>B-00816467020044</basicUdiDi>
    <tradeName>00816467020044</tradeName>
    <deviceName>FastPack Testo Calibrator</deviceName>
    <manufacturerName>Qualigen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025168</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25000014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:00:46.850Z</lastUpdated>
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    <udiDi>40816467020318</udiDi>
    <basicUdiDi>B-40816467020318</basicUdiDi>
    <tradeName>40816467020318</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Qualigen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025168</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25000079</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:24:14.117Z</lastUpdated>
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    <udiDi>10816467020157</udiDi>
    <basicUdiDi>B-10816467020157</basicUdiDi>
    <tradeName>10816467020157</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Qualigen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025168</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25000068</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:11:42.123Z</lastUpdated>
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    <udiDi>20816467020031</udiDi>
    <basicUdiDi>B-20816467020031</basicUdiDi>
    <tradeName>20816467020031</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Qualigen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025168</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25000041</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:52:29.215Z</lastUpdated>
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    <udiDi>20816467020086</udiDi>
    <basicUdiDi>B-20816467020086</basicUdiDi>
    <tradeName>20816467020086</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Qualigen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025168</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25000042</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:52:29.021Z</lastUpdated>
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    <udiDi>20816467020055</udiDi>
    <basicUdiDi>B-20816467020055</basicUdiDi>
    <tradeName>20816467020055</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Qualigen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025168</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25000043</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:52:28.882Z</lastUpdated>
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    <udiDi>10816467020126</udiDi>
    <basicUdiDi>B-10816467020126</basicUdiDi>
    <tradeName>10816467020126</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Qualigen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025168</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25000044</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:52:28.743Z</lastUpdated>
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