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    <manufacturerName>BGI EUROPE A/S</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
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    <basicUdiDi>5745000468EU02000500019R</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU0200050007 (PBC22 Plus)</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
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    <udiDi>05745000468485</udiDi>
    <basicUdiDi>5745000468EU02000500019R</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0201010102</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:26.616Z</lastUpdated>
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    <udiDi>05055273206043</udiDi>
    <basicUdiDi>50552732AWASCON008NK</basicUdiDi>
    <tradeName>RX WASH CONCENTRATE (WASH conc. 2)</tradeName>
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    <manufacturerName>Randox Laboratories Limited</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <reference>RX4041</reference>
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    <tradeName>C1 SOLUTION (C1 SOLN)</tradeName>
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    <manufacturerName>Randox Laboratories Limited</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RX8143</reference>
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    <lastUpdated>2026-06-21T18:35:26.949Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RX2911</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:35:25.912Z</lastUpdated>
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    <tradeName>I.S.E. Diluent (ISE DIL)</tradeName>
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    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RX2912</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:35:25.899Z</lastUpdated>
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    <tradeName>Mission U500 Urine Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acon Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006977</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U211-111-201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:04:26.990Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Acon Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006977</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
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    <emdnCode>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
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    <reference>U211-107-201</reference>
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    <lastUpdated>2026-06-20T22:04:26.975Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Acon Biotech (Hangzhou) Co., Ltd.</manufacturerName>
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    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
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    <reference>U211-117-201</reference>
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    <manufacturerName>Acon Biotech (Hangzhou) Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U213-117-201</reference>
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    <deviceName></deviceName>
    <manufacturerName>Acon Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006977</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
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    <emdnCode>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U117-111-201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:04:26.886Z</lastUpdated>
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    <tradeName>Quik-Check Expert U120 Smart Urine Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acon Biotech (Hangzhou) Co., Ltd.</manufacturerName>
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    <emdnCode>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U118-111-201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:04:26.844Z</lastUpdated>
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    <tradeName>Acid Washing Solution</tradeName>
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    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP2209</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:29.117Z</lastUpdated>
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    <tradeName>Alkaline Washing Solution</tradeName>
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    <manufacturerName>Biolis Medical Corp.</manufacturerName>
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    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50-24-0747</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:28.927Z</lastUpdated>
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