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    <tradeName>VALIDATE® GC1 Test Set</tradeName>
    <deviceName>VALIDATE® GC1 Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050102</emdnCode>
    <emdnDescription>UNASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1100wa</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:58:58.951Z</lastUpdated>
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    <udiDi>00850011135389</udiDi>
    <basicUdiDi>B-00850011135389</basicUdiDi>
    <tradeName>VALIDATE® BODY FLUIDS 3 Test Set</tradeName>
    <deviceName>VALIDATE® BODY FLUIDS 3 Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050102</emdnCode>
    <emdnDescription>UNASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>207RO</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:58:46.929Z</lastUpdated>
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    <udiDi>00850011135198</udiDi>
    <basicUdiDi>B-00850011135198</basicUdiDi>
    <tradeName>VALIDATE® BODY FLUIDS 2 Test Set</tradeName>
    <deviceName>VALIDATE® BODY FLUIDS 2 Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0101050102</emdnCode>
    <emdnDescription>UNASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>206ro</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:58:18.929Z</lastUpdated>
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    <udiDi>05055273206807</udiDi>
    <basicUdiDi>50552732BHUPNCN127PL</basicUdiDi>
    <tradeName>HUMAN PRECISION CONTROL - LEVEL 2 (HUM PREC CONTROL 2)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050102</emdnCode>
    <emdnDescription>UNASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UN1557</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:35:27.537Z</lastUpdated>
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    <udiDi>05055273207149</udiDi>
    <basicUdiDi>50552732BCUQCON121KT</basicUdiDi>
    <tradeName>LIQUID CHEMISTRY PREMIUM PLUS - LEVEL 2 (LIQ CHEM PREMIUM PLUS 2)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050102</emdnCode>
    <emdnDescription>UNASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LUN5070</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:35:27.470Z</lastUpdated>
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    <udiDi>05055273207156</udiDi>
    <basicUdiDi>50552732BCUQCON121KT</basicUdiDi>
    <tradeName>LIQUID CHEMISTRY PREMIUM PLUS - LEVEL 3 (LIQ CHEM PREMIUM PLUS 3)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050102</emdnCode>
    <emdnDescription>UNASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LUE5071</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:35:27.459Z</lastUpdated>
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    <udiDi>05055273210118</udiDi>
    <basicUdiDi>50552732BLIACON169BJ</basicUdiDi>
    <tradeName>Liquid Immunoassay Control - Level 2 (IA CONTROL 2)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050102</emdnCode>
    <emdnDescription>UNASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LIA5143</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:35:27.214Z</lastUpdated>
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    <udiDi>05055273210125</udiDi>
    <basicUdiDi>50552732BLIACON169BJ</basicUdiDi>
    <tradeName>Liquid Immunoassay Control - Level 3 (IA CONTROL 3)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050102</emdnCode>
    <emdnDescription>UNASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LIA5144</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:35:27.203Z</lastUpdated>
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    <udiDi>05055273216585</udiDi>
    <basicUdiDi>50552732BCUQCON121KT</basicUdiDi>
    <tradeName>CUSTOM LIQUID CHEMISTRY CONTROL LEVEL 3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050102</emdnCode>
    <emdnDescription>UNASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LUE5169</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:35:26.496Z</lastUpdated>
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    <udiDi>05055273216592</udiDi>
    <basicUdiDi>50552732BCUQCON121KT</basicUdiDi>
    <tradeName>CUSTOM LIQUID CHEMISTRY CONTROL LEVEL 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050102</emdnCode>
    <emdnDescription>UNASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LUN5168</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:35:26.483Z</lastUpdated>
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    <udiDi>05055273216608</udiDi>
    <basicUdiDi>50552732BCUQCON121KT</basicUdiDi>
    <tradeName>CUSTOM LIQUID CHEMISTRY CONTROL LEVEL 1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050102</emdnCode>
    <emdnDescription>UNASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LUL5167</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:35:26.462Z</lastUpdated>
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    <udiDi>05055273218732</udiDi>
    <basicUdiDi>50552732BXTHPON1553F</basicUdiDi>
    <tradeName>XANTHOCHROMIA NEGATIVE CONTROL (XANTHOCHROMIA CONTROL -)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050102</emdnCode>
    <emdnDescription>UNASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XN10502</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:35:25.948Z</lastUpdated>
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