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    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® aCL IgM Reagents</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100501</emdnCode>
    <emdnDescription>ANTI-CARDIOLIPIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701238</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:19:17.855Z</lastUpdated>
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    <udiDi>08426950544203</udiDi>
    <basicUdiDi>B-08426950544203</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® aCL IgG Reagents</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100501</emdnCode>
    <emdnDescription>ANTI-CARDIOLIPIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701233</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:19:16.265Z</lastUpdated>
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    <udiDi>08426950544197</udiDi>
    <basicUdiDi>B-08426950544197</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® MPO Reagents</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701133</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:19:15.444Z</lastUpdated>
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    <udiDi>08426950544173</udiDi>
    <basicUdiDi>B-08426950544173</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® DGP IgA Reagents</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100604</emdnCode>
    <emdnDescription>GLIADIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701168</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:19:13.842Z</lastUpdated>
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    <udiDi>08426950544166</udiDi>
    <basicUdiDi>B-08426950544166</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® DGP IgG Reagents</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100604</emdnCode>
    <emdnDescription>GLIADIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701173</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:19:11.468Z</lastUpdated>
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    <udiDi>08426950544159</udiDi>
    <basicUdiDi>B-08426950544159</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® h-tTG IgG Reagents</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100601</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701108</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:19:09.855Z</lastUpdated>
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    <udiDi>08426950514213</udiDi>
    <basicUdiDi>B-08426950514213</basicUdiDi>
    <tradeName>QUANTA Lite</tradeName>
    <deviceName>QUANTA Lite® ASCA IgA ELISA</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109018</emdnCode>
    <emdnDescription>SACCHAROMYCES CEREVISIAE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>708870</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:19:09.062Z</lastUpdated>
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    <udiDi>08426950514206</udiDi>
    <basicUdiDi>B-08426950514206</basicUdiDi>
    <tradeName>QUANTA Lite</tradeName>
    <deviceName>QUANTA Lite® ASCA IgG ELISA</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109018</emdnCode>
    <emdnDescription>SACCHAROMYCES CEREVISIAE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>708865</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:19:07.445Z</lastUpdated>
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    <udiDi>08426950514190</udiDi>
    <basicUdiDi>B-08426950514190</basicUdiDi>
    <tradeName>QUANTA Lite</tradeName>
    <deviceName>QUANTA Lite® C1q CIC ELISA</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010201</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C1Q</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>704620</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:19:05.036Z</lastUpdated>
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    <udiDi>08426950514176</udiDi>
    <basicUdiDi>B-08426950514176</basicUdiDi>
    <tradeName>NOVA Lite</tradeName>
    <deviceName>NOVA Lite® Rat Liver, Kidney, Stomach Kit</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>704170</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:19:03.501Z</lastUpdated>
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    <udiDi>08426950514008</udiDi>
    <basicUdiDi>B-08426950514008</basicUdiDi>
    <tradeName>NOVA Lite</tradeName>
    <deviceName>NOVA Lite® ANA KSL Kit</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>708380</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:19:02.629Z</lastUpdated>
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    <udiDi>08426950513995</udiDi>
    <basicUdiDi>B-08426950513995</basicUdiDi>
    <tradeName>NOVA Lite</tradeName>
    <deviceName>NOVA Lite® ANCA Kit</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100401</emdnCode>
    <emdnDescription>ANCA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>708296</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:19:01.046Z</lastUpdated>
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    <udiDi>08426950513988</udiDi>
    <basicUdiDi>B-08426950513988</basicUdiDi>
    <tradeName>NOVA Lite</tradeName>
    <deviceName>NOVA Lite® Monkey Oesophagus IFA Kit</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100603</emdnCode>
    <emdnDescription>ANTIBODIES TO ENDOMYSIAL AUTOANTIGENES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>704145</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:18:58.631Z</lastUpdated>
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    <udiDi>08426950512912</udiDi>
    <basicUdiDi>B-08426950512912</basicUdiDi>
    <tradeName>NOVA Lite</tradeName>
    <deviceName>NOVA Lite® ANCA Kit</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100401</emdnCode>
    <emdnDescription>ANCA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>708298</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:18:57.039Z</lastUpdated>
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    <udiDi>08426950506355</udiDi>
    <basicUdiDi>B-08426950506355</basicUdiDi>
    <tradeName>QUANTA Lite</tradeName>
    <deviceName>QUANTA Lite® Chromatin ELISA</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>708710</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:18:56.231Z</lastUpdated>
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    <udiDi>08426950506362</udiDi>
    <basicUdiDi>B-08426950506362</basicUdiDi>
    <tradeName>QUANTA Lite</tradeName>
    <deviceName>QUANTA Lite® RNA Pol III ELISA</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>704555</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:18:54.627Z</lastUpdated>
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    <udiDi>08426950506324</udiDi>
    <basicUdiDi>B-08426950506324</basicUdiDi>
    <tradeName>NOVA Lite</tradeName>
    <deviceName>NOVA Lite® ANA KSL Kit</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>708390</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:18:52.226Z</lastUpdated>
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    <udiDi>08426950506331</udiDi>
    <basicUdiDi>B-08426950506331</basicUdiDi>
    <tradeName>QUANTA Lite</tradeName>
    <deviceName>QUANTA Lite® Histone ELISA</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100107</emdnCode>
    <emdnDescription>HISTONES (H1, H2A, H3, H4,…HN)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>708520</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:18:50.745Z</lastUpdated>
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    <udiDi>08426950485094</udiDi>
    <basicUdiDi>B-08426950485094</basicUdiDi>
    <tradeName>QUANTA Lite</tradeName>
    <deviceName>QUANTA Lite® Actin IgG ELISA</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100701</emdnCode>
    <emdnDescription>HEPATITIS AUTOANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>708785</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:18:36.943Z</lastUpdated>
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    <udiDi>08426950456216</udiDi>
    <basicUdiDi>B-08426950456216</basicUdiDi>
    <tradeName>NOVA Lite</tradeName>
    <deviceName>NOVA Lite® ANCA Kit</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100401</emdnCode>
    <emdnDescription>ANCA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>708290</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:18:35.357Z</lastUpdated>
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