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    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® ENA7 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>W0102100102</emdnCode>
    <emdnDescription>ENA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701255</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:22:04.572Z</lastUpdated>
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    <basicUdiDi>B-08426950627814</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® CTD Screen Plus Controls</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>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701222</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:22:02.972Z</lastUpdated>
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    <basicUdiDi>B-08426950627807</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® CTD Screen Plus Calibrators</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>
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    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:22:02.167Z</lastUpdated>
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    <basicUdiDi>B-08426950627791</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® CTD Screen Plus 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>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701220</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:22:00.568Z</lastUpdated>
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    <udiDi>08426950627753</udiDi>
    <basicUdiDi>B-08426950627753</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>701170</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:21:58.163Z</lastUpdated>
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    <udiDi>08426950627760</udiDi>
    <basicUdiDi>B-08426950627760</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® dsDNA 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>W0102100105</emdnCode>
    <emdnDescription>DS DNA - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701175</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:21:56.560Z</lastUpdated>
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    <udiDi>08426950624646</udiDi>
    <basicUdiDi>B-08426950624646</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® dsDNA 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>W0102100105</emdnCode>
    <emdnDescription>DS DNA - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701178</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:21:55.796Z</lastUpdated>
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    <udiDi>08426950627685</udiDi>
    <basicUdiDi>B-08426950627685</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>701130</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:21:54.163Z</lastUpdated>
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    <udiDi>08426950622208</udiDi>
    <basicUdiDi>B-08426950622208</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® CCP3 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>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701125</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:21:38.903Z</lastUpdated>
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    <udiDi>08426950622192</udiDi>
    <basicUdiDi>B-08426950622192</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® CCP3 Controls</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>W0102152010</emdnCode>
    <emdnDescription>CONTROLS FOR RHEUMATOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701127</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:21:37.308Z</lastUpdated>
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    <udiDi>08426950622185</udiDi>
    <basicUdiDi>B-08426950622185</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® CCP3 Calibrators</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>W0102152210</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR RHEUMATOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701126</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:21:36.509Z</lastUpdated>
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    <udiDi>08426950621843</udiDi>
    <basicUdiDi>B-08426950621843</basicUdiDi>
    <tradeName>NOVA Lite</tradeName>
    <deviceName>NOVA Lite® DAPI ANA 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>704320</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:21:34.915Z</lastUpdated>
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    <udiDi>08426950602002</udiDi>
    <basicUdiDi>B-08426950602002</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® DFS70 Controls</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>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701267</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:21:32.501Z</lastUpdated>
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    <udiDi>08426950601999</udiDi>
    <basicUdiDi>B-08426950601999</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® DFS70 Calibrators</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>W0102152211</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701266</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:21:30.916Z</lastUpdated>
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    <udiDi>08426950601975</udiDi>
    <basicUdiDi>B-08426950601975</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® Ribosomal P Controls</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>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701192</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:21:30.098Z</lastUpdated>
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    <udiDi>08426950601968</udiDi>
    <basicUdiDi>B-08426950601968</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® Ribosomal P Calibrators</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>W0102152211</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701191</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:21:28.499Z</lastUpdated>
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    <udiDi>08426950601951</udiDi>
    <basicUdiDi>B-08426950601951</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® B2GP1-Domain 1 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>W0102100503</emdnCode>
    <emdnDescription>ANTI-B2-GLYCOPROTEIN I ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701188</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:21:26.100Z</lastUpdated>
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    <udiDi>08426950601944</udiDi>
    <basicUdiDi>B-08426950601944</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® B2GP1-Domain1 Controls</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>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701187</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:21:24.496Z</lastUpdated>
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    <udiDi>08426950601920</udiDi>
    <basicUdiDi>B-08426950601920</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® dsDNA Controls</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>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701177</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:21:23.691Z</lastUpdated>
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    <udiDi>08426950601913</udiDi>
    <basicUdiDi>B-08426950601913</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® dsDNA Calibrators</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>W0102152211</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701176</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:21:22.092Z</lastUpdated>
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