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    <manufacturerName>Randox Laboratories Limited</manufacturerName>
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    <tradeName>SERUM DILUENT (DIL SM)</tradeName>
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    <tradeName>Hemolysis Solution</tradeName>
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    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
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    <tradeName>HEMOLYSIS WASHING SOLUTION Lite H</tradeName>
    <deviceName>HEMOLYSIS WASHING SOLUTION Lite H</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
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    <emdnCode>W01019001</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>107378</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
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    <tradeName>DILUENT 90</tradeName>
    <deviceName>DILUENT 90</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
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    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
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    <tradeName>HEMOLYSIS WASHING SOLUTION 90H</tradeName>
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    <tradeName>CONTROL DILUTION SET 80</tradeName>
    <deviceName>CONTROL DILUTION SET 80</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
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    <reference>107350</reference>
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    <lastUpdated>2026-07-31T04:33:07.666Z</lastUpdated>
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    <tradeName>HEMOLYSIS WASHING SOLUTION 80H</tradeName>
    <deviceName>HEMOLYSIS WASHING SOLUTION 80H</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
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    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107349</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:03.512Z</lastUpdated>
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    <tradeName>FIT AA01 Specimen Diluent</tradeName>
    <deviceName>FIT AA01 Specimen Diluent</deviceName>
    <manufacturerName>Alfresa Pharma Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008778</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>913937</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:32:31.503Z</lastUpdated>
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    <tradeName>FIT NS-Prime Specimen Diluent</tradeName>
    <deviceName>FIT NS-Prime Specimen Diluent</deviceName>
    <manufacturerName>Alfresa Pharma Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008778</manufacturerSrn>
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    <riskClass>IVD Sınıf A</riskClass>
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    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>910874</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:32:00.362Z</lastUpdated>
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    <udiDi>04270003742504</udiDi>
    <basicUdiDi>42700037425CATfluxGN</basicUdiDi>
    <tradeName>CatFlux Solutions</tradeName>
    <deviceName>CatFlux Solutions for the CatSper Test, CatFlux Control and Test Solution</deviceName>
    <manufacturerName>Truion GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000034807</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P1001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:47:34.139Z</lastUpdated>
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    <tradeName>-	deltaPREP Blood DNA Kit – PP Mini (MDX) Strip 96 rxn</tradeName>
    <deviceName>deltaPREP Blood DNA Kit – PP Mini (MDX)</deviceName>
    <manufacturerName>IST Innuscreen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31-DP-7000096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:29:43.235Z</lastUpdated>
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    <tradeName>PurePrep Path DX Kit (96 rxn)</tradeName>
    <deviceName>deltaPREP Virus PLUS Kit - Multi-Device 96 (MDX)</deviceName>
    <manufacturerName>IST Innuscreen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MGV000483</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:29:42.438Z</lastUpdated>
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    <basicUdiDi>4262375220038M</basicUdiDi>
    <tradeName>deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (96 rxn) Sprips</tradeName>
    <deviceName>deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (16rxn) Stripes</deviceName>
    <manufacturerName>IST Innuscreen GmbH</manufacturerName>
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    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31-DP-5010096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:29:41.635Z</lastUpdated>
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    <tradeName>deltaPREP Blood DNA Mini Kit – IPC16 (MDX) (96 rxn) stripes</tradeName>
    <deviceName>deltaPREP Blood DNA Mini Kit – IPC16 (MDX)</deviceName>
    <manufacturerName>IST Innuscreen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024606</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:29:40.836Z</lastUpdated>
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    <tradeName>-	deltaPREP Blood DNA Kit – PP Mini (MDX) Strip 16 rxn</tradeName>
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    <manufacturerName>IST Innuscreen GmbH</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <tradeName>deltaPREP Virus PLUS Kit - Multi-Device 96 (MDX) (480 rxn)</tradeName>
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    <manufacturerName>IST Innuscreen GmbH</manufacturerName>
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    <reference>31-DP-2000480</reference>
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    <tradeName>deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (16 rxn) Plates</tradeName>
    <deviceName>deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (16rxn) Stripes</deviceName>
    <manufacturerName>IST Innuscreen GmbH</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>deltaPREP Blood DNA Mini Kit – IPC16 (MDX) (16 rxn) Plates</tradeName>
    <deviceName>deltaPREP Blood DNA Mini Kit – IPC16 (MDX)</deviceName>
    <manufacturerName>IST Innuscreen GmbH</manufacturerName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:23:01.971Z</lastUpdated>
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