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    <manufacturerName>Medicon Hellas SA</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:52:42.746Z</lastUpdated>
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    <manufacturerName>Medicon Hellas SA</manufacturerName>
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    <manufacturerName>Medicon Hellas SA</manufacturerName>
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    <tradeName>QIAcuityDx Universal MasterMix Kit (1mL)</tradeName>
    <deviceName>QIAcuityDx Universal MasterMix Kit</deviceName>
    <manufacturerName>QIAGEN GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004949</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>260101</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:24:02.932Z</lastUpdated>
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    <basicUdiDi>4050598LCACPhysiolLL</basicUdiDi>
    <tradeName>UPLC column</tradeName>
    <deviceName>Accessories for Pregnolone sulfate LC-MS/MS</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM2000SP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:16:28.312Z</lastUpdated>
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    <udiDi>03366160500260</udiDi>
    <basicUdiDi>3661605DD0DIG00B6</basicUdiDi>
    <tradeName>Digest-EUR</tradeName>
    <deviceName>Digest-EUR</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD0DIG00-AI</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T10:22:23.758Z</lastUpdated>
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    <udiDi>03366160501236</udiDi>
    <basicUdiDi>33661605EBE0774L</basicUdiDi>
    <tradeName>EurobioPlex DermaXtract</tradeName>
    <deviceName>EurobioPlex DermaXtract</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBE-077-50</reference>
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    <tradeName>AutoChem PA Calibrator</tradeName>
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    <manufacturerName>Autobio Biochemistry Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000038143</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>360101PA00S11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:09:29.256Z</lastUpdated>
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    <deviceName>Fungus(1-3)-β-D-Glucan Test (Chromogenic Method)</deviceName>
    <manufacturerName>Beijing Gold Mountainriver Tech Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028661</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCT-110T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T00:55:27.166Z</lastUpdated>
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    <udiDi>06970489560286</udiDi>
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    <deviceName>Fungus(1-3)-β-D-Glucan Test (Chromogenic Method)</deviceName>
    <manufacturerName>Beijing Gold Mountainriver Tech Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028661</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKT-25M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T00:55:25.963Z</lastUpdated>
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    <tradeName>06970489560279</tradeName>
    <deviceName>Fungus(1-3)-β-D-Glucan Test (Chromogenic Method)</deviceName>
    <manufacturerName>Beijing Gold Mountainriver Tech Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028661</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKT-12M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T00:55:19.962Z</lastUpdated>
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    <udiDi>06970489560262</udiDi>
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    <tradeName>06970489560262</tradeName>
    <deviceName>Fungus(1-3)-β-D-Glucan Test (Chromogenic Method)</deviceName>
    <manufacturerName>Beijing Gold Mountainriver Tech Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028661</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKT-10M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T00:55:18.757Z</lastUpdated>
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    <udiDi>06970489560255</udiDi>
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    <tradeName>06970489560255</tradeName>
    <deviceName>Fungus(1-3)-β-D-Glucan Test (Chromogenic Method)</deviceName>
    <manufacturerName>Beijing Gold Mountainriver Tech Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028661</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKT-5M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T00:55:17.556Z</lastUpdated>
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    <udiDi>08908023154033</udiDi>
    <basicUdiDi>8908023154CandoreROSMC</basicUdiDi>
    <tradeName>CANros</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Candore Bioscience</manufacturerName>
    <manufacturerSrn>IN-MF-000038606</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA-002/20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:19:47.809Z</lastUpdated>
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    <udiDi>06942253015476</udiDi>
    <basicUdiDi>69422530000013N7</basicUdiDi>
    <tradeName>PA Clinchem Control Q1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Biochemistry Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000038143</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
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    <reference>360101PA00Q11</reference>
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    <lastUpdated>2026-06-29T03:38:17.632Z</lastUpdated>
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    <tradeName>PA Clinchem Control Q2</tradeName>
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    <manufacturerName>Autobio Biochemistry Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000038143</manufacturerSrn>
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    <lastUpdated>2026-06-29T03:38:17.441Z</lastUpdated>
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    <manufacturerName>AVE Science &amp; Technology Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:35:19.440Z</lastUpdated>
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    <lastUpdated>2026-06-28T18:35:12.229Z</lastUpdated>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <manufacturerName>AVE Science &amp; Technology Co., Ltd.</manufacturerName>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:35:08.623Z</lastUpdated>
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