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    <udiDi>D-910201P3</udiDi>
    <basicUdiDi>B-910201P3</basicUdiDi>
    <tradeName>spinit®</tradeName>
    <deviceName>spinit® BC control</deviceName>
    <manufacturerName>biosurfit SA</manufacturerName>
    <manufacturerSrn>PT-MF-000033920</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>LEUCOCYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>910201</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:55:21.390Z</lastUpdated>
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    <udiDi>D-737664RU</udiDi>
    <basicUdiDi>B-737664RU</basicUdiDi>
    <tradeName>PC7 (770/488) SETUP KIT</tradeName>
    <deviceName>PC7 (770/488) SETUP KIT</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0103080401</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>737664</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:14.144Z</lastUpdated>
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    <udiDi>D-737663RS</udiDi>
    <basicUdiDi>B-737663RS</basicUdiDi>
    <tradeName>APC (675/633) Setup Kit</tradeName>
    <deviceName>APC (675/633) Setup Kit</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0103080401</emdnCode>
    <emdnDescription>SETUP BEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>737663</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:13.346Z</lastUpdated>
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    <udiDi>D-737662RQ</udiDi>
    <basicUdiDi>B-737662RQ</basicUdiDi>
    <tradeName>IOTest MslgG1-PC7</tradeName>
    <deviceName>IOTest MslgG1-PC7</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>737662</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:08.531Z</lastUpdated>
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    <udiDi>D-175658QH</udiDi>
    <basicUdiDi>B-175658QH</basicUdiDi>
    <tradeName>Leuko-Trol RBC Control Cells</tradeName>
    <deviceName>Leuko-Trol RBC Control Cells</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>175658</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:17:16.405Z</lastUpdated>
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    <udiDi>D-175651Q3</udiDi>
    <basicUdiDi>B-175651Q3</basicUdiDi>
    <tradeName>Leuko-Trol Platelet Control Cells</tradeName>
    <deviceName>Leuko-Trol Platelet Control Cells</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080403</emdnCode>
    <emdnDescription>LYMPHOCYTE SUBTYPING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>175651</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:17:15.615Z</lastUpdated>
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    <udiDi>15099590225865</udiDi>
    <basicUdiDi>150995902LSIMMUNOTROLZ6</basicUdiDi>
    <tradeName>AQUIOS Immuno-Trol Low Cells</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103080403</emdnCode>
    <emdnDescription>LYMPHOCYTE SUBTYPING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B25700</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:23:17.099Z</lastUpdated>
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    <udiDi>06975309200403</udiDi>
    <basicUdiDi>697530920305JU</basicUdiDi>
    <tradeName>IsFlower QC Beads</tradeName>
    <deviceName>IsFlower QC Beads</deviceName>
    <manufacturerName>Beijing Challen Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023656</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080401</emdnCode>
    <emdnDescription>SETUP BEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C.Mb.0007</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:36:52.918Z</lastUpdated>
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    <udiDi>15099590670429</udiDi>
    <basicUdiDi>150995903B49179TA</basicUdiDi>
    <tradeName>IgG1(mouse)-FITC/IgG2a(mouse)-PE</tradeName>
    <deviceName>IgG1(mouse)-FITC/IgG2a(mouse)-PE</deviceName>
    <manufacturerName>IMMUNOTECH SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000011121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B49179</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:56:15.489Z</lastUpdated>
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    <udiDi>15099590731519</udiDi>
    <basicUdiDi>150995903ASTEMCONTROLGF</basicUdiDi>
    <tradeName>AQUIOS STEM CD34 Control Cells</tradeName>
    <deviceName>AQUIOS STEM CD34 Control Cells</deviceName>
    <manufacturerName>IMMUNOTECH SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000011121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080404</emdnCode>
    <emdnDescription>STEM CELL ENUMERATION CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C43667</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:50:25.455Z</lastUpdated>
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    <udiDi>15099590694982</udiDi>
    <basicUdiDi>150995902CLCompBeadEV</basicUdiDi>
    <tradeName>ClearLLab Compensation Beads</tradeName>
    <deviceName>ClearLLab Compensation Beads</deviceName>
    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080401</emdnCode>
    <emdnDescription>SETUP BEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B99883</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:50:17.443Z</lastUpdated>
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    <udiDi>15099590694968</udiDi>
    <basicUdiDi>150995902CLControlCellsRW</basicUdiDi>
    <tradeName>ClearLLab Control Cells Normal</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080403</emdnCode>
    <emdnDescription>LYMPHOCYTE SUBTYPING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B90002</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:50:15.347Z</lastUpdated>
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    <udiDi>15099590663698</udiDi>
    <basicUdiDi>150995902LSFLOWCOUNTPM</basicUdiDi>
    <tradeName>Aquios Flow Count 100 test</tradeName>
    <deviceName>AQUIOS Flow Count</deviceName>
    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B43611</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:49:26.951Z</lastUpdated>
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    <udiDi>15099590542450</udiDi>
    <basicUdiDi>150995901FLUROSPHRSRP</basicUdiDi>
    <tradeName>Flow-Count Fluorospheres</tradeName>
    <deviceName>Flow-Count Fluorospheres</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7547053</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:38:36.525Z</lastUpdated>
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    <udiDi>15099590540210</udiDi>
    <basicUdiDi>150995901LSIMMUNOTROLXV</basicUdiDi>
    <tradeName>IMMUNO-TROL Low Cells</tradeName>
    <deviceName>IMMUNO-TROL Cells</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080403</emdnCode>
    <emdnDescription>LYMPHOCYTE SUBTYPING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6607098</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:38:30.912Z</lastUpdated>
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    <tradeName>IMMUNO-TROL Cells</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <reference>6607077</reference>
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    <lastUpdated>2026-06-29T10:49:46.755Z</lastUpdated>
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    <tradeName>COULTER CYTO-TROL Control Cells Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <emdnCode>W0103080403</emdnCode>
    <emdnDescription>LYMPHOCYTE SUBTYPING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6604248</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:49:46.731Z</lastUpdated>
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    <udiDi>15099590663704</udiDi>
    <basicUdiDi>150995902LSFLOWCOUNTPM</basicUdiDi>
    <tradeName>AQUIOS Flow-Count</tradeName>
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    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>B52937</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:49:44.614Z</lastUpdated>
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    <tradeName>AQUIOS ImmunoTrol Cells (Tetra/PLG)</tradeName>
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    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
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    <emdnDescription>LYMPHOCYTE SUBTYPING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B45229</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:49:44.595Z</lastUpdated>
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    <tradeName>AQUIOS Immuno-Trol Low Cells (Tetra/PLG)</tradeName>
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    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
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    <emdnDescription>LYMPHOCYTE SUBTYPING CONTROLS</emdnDescription>
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