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    <tradeName>HLA-B27 Reagent</tradeName>
    <deviceName>HLA-B27 Reagent</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080101</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-034921-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:50:07.940Z</lastUpdated>
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    <udiDi>06903053047401</udiDi>
    <basicUdiDi>69449040AB70000023L</basicUdiDi>
    <tradeName>CD3-FITC/CD16+56-PE/CD45-PerCP/CD19-APC Reagent</tradeName>
    <deviceName>CD3-FITC/CD16+56-PE/CD45-PerCP/CD19-APC Reagent</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-035114-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:50:07.415Z</lastUpdated>
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    <udiDi>06903053047395</udiDi>
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    <tradeName>CD3-FITC/CD8-PE/CD45-PerCP/CD4-APC Reagent</tradeName>
    <deviceName>CD3-FITC/CD8-PE/CD45-PerCP/CD4-APC Reagent</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
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    <emdnCode>W0103080101</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-035033-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:50:07.304Z</lastUpdated>
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    <udiDi>15099590391522</udiDi>
    <basicUdiDi>150995901LSANTIBODYREAQ2</basicUdiDi>
    <tradeName>IOTest CD8-PC7</tradeName>
    <deviceName>Monoclonal Antibody</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>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>737661</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:35:39.843Z</lastUpdated>
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    <udiDi>D-6607072ZJ</udiDi>
    <basicUdiDi>B-6607072ZJ</basicUdiDi>
    <tradeName>CYTO-STAT triCHROME CD45-FITC/CD19-RD1 ICD3-PC5</tradeName>
    <deviceName>CYTO-STAT triCHROME CD45-FITC/CD19-RD1 ICD3-PC5</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>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6607072</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:46:26.169Z</lastUpdated>
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    <udiDi>D-6607071ZG</udiDi>
    <basicUdiDi>B-6607071ZG</basicUdiDi>
    <tradeName>CYTO-STAT triCHROME CD45-FITC/CD56-RD1/CD3-PC5</tradeName>
    <deviceName>CYTO-STAT triCHROME CD45-FITC/CD56-RD1/CD3-PC5</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>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6607071</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:46:25.085Z</lastUpdated>
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    <udiDi>D-6607053ZE</udiDi>
    <basicUdiDi>B-6607053ZE</basicUdiDi>
    <tradeName>CYTO-STAT triCHROME CD8-FITC/CD4-RD1/CD3-PC5</tradeName>
    <deviceName>CYTO-STAT triCHROME CD8-FITC/CD4-RD1/CD3-PC5</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>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6607053</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:46:18.350Z</lastUpdated>
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    <udiDi>D-6607017ZA</udiDi>
    <basicUdiDi>B-6607017ZA</basicUdiDi>
    <tradeName>Cyto-Stat Tirchrome CD45-FITC/CD8-RD1/CD3-PC5</tradeName>
    <deviceName>Cyto-Stat Tirchrome CD45-FITC/CD8-RD1/CD3-PC5</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>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6607017</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:46:13.055Z</lastUpdated>
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    <udiDi>D-6607015Z6</udiDi>
    <basicUdiDi>B-6607015Z6</basicUdiDi>
    <tradeName>CYTO-STAT triCHROME CD45-FITC/CD4-RD1/CD3-PC5</tradeName>
    <deviceName>CYTO-STAT triCHROME CD45-FITC/CD4-RD1/CD3-PC5</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>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6607015</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:46:12.119Z</lastUpdated>
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    <udiDi>D-6607013Z2</udiDi>
    <basicUdiDi>B-6607013Z2</basicUdiDi>
    <tradeName>CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5</tradeName>
    <deviceName>CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5</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>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6607013</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:46:12.050Z</lastUpdated>
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    <udiDi>D-66049292C</udiDi>
    <basicUdiDi>B-66049292C</basicUdiDi>
    <tradeName>CYTO-STAT/COULTER CLONE CD3(IgG1)-FITC/T4-RD1</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE CD3(IgG1)-FITC/T4-RD1</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>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6604929</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:46:02.990Z</lastUpdated>
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    <udiDi>D-6604614ZD</udiDi>
    <basicUdiDi>B-6604614ZD</basicUdiDi>
    <tradeName>CYTO-STAT/COULTER CLONE T8-RD1/T4-FITC</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE T8-RD1/T4-FITC</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>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6604614</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:45:51.600Z</lastUpdated>
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    <udiDi>D-660392823</udiDi>
    <basicUdiDi>B-660392823</basicUdiDi>
    <tradeName>CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC</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>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6603928</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:45:22.799Z</lastUpdated>
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    <udiDi>D-6603801Z7</udiDi>
    <basicUdiDi>B-6603801Z7</basicUdiDi>
    <tradeName>CYTO-STAT/COULTER CLONE T11-RD1/B4-FITC</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE T11-RD1/B4-FITC</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6603801</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:44:53.171Z</lastUpdated>
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    <udiDi>D-6603802Z9</udiDi>
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    <tradeName>CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6603802</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:44:50.780Z</lastUpdated>
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    <udiDi>00382903457762</udiDi>
    <basicUdiDi>038290OZKDOEIGHX</basicUdiDi>
    <tradeName>Not Applicable</tradeName>
    <deviceName>BD® CD19</deviceName>
    <manufacturerName>Becton, Dickinson and Company, BD Biosciences</manufacturerName>
    <manufacturerSrn>US-MF-000017797</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
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    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
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    <reference>345776</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:43:30.441Z</lastUpdated>
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    <tradeName>BD MULTITEST</tradeName>
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    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>340503</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:43:28.313Z</lastUpdated>
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    <tradeName>Not Applicable</tradeName>
    <deviceName>BD® CD79b (SN8)</deviceName>
    <manufacturerName>Becton, Dickinson and Company, BD Biosciences</manufacturerName>
    <manufacturerSrn>US-MF-000017797</manufacturerSrn>
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    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
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    <reference>335832</reference>
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    <lastUpdated>2026-07-15T20:43:28.276Z</lastUpdated>
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    <tradeName>Not Applicable</tradeName>
    <deviceName>CD5 Single Color Reagents</deviceName>
    <manufacturerName>Becton, Dickinson and Company, BD Biosciences</manufacturerName>
    <manufacturerSrn>US-MF-000017797</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
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    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
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    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:43:25.038Z</lastUpdated>
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    <tradeName>Not Applicable</tradeName>
    <deviceName>BD® CD22 (S-HCL-1)</deviceName>
    <manufacturerName>Becton, Dickinson and Company, BD Biosciences</manufacturerName>
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    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>333145</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:43:08.280Z</lastUpdated>
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