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<eudamedExport entity="devices">
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    <tradeName>IOTest CD8-PC7</tradeName>
    <deviceName>IOTest CD8-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>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>737661</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:07.733Z</lastUpdated>
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  <row>
    <udiDi>D-737660RL</udiDi>
    <basicUdiDi>B-737660RL</basicUdiDi>
    <tradeName>IOTest CD4-PC7</tradeName>
    <deviceName>IOTest CD4-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>W0103080199</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>737660</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:06.938Z</lastUpdated>
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  <row>
    <udiDi>D-737659S3</udiDi>
    <basicUdiDi>B-737659S3</basicUdiDi>
    <tradeName>CYTO-STAT/COULTER CLONE CD8-ECD</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE CD8-ECD</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>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>737659</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:06.129Z</lastUpdated>
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  <row>
    <udiDi>D-737657RX</udiDi>
    <basicUdiDi>B-737657RX</basicUdiDi>
    <tradeName>IOTest CD3-PC7</tradeName>
    <deviceName>IOTest CD3-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>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>737657</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:02.131Z</lastUpdated>
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  <row>
    <udiDi>15061002300019</udiDi>
    <basicUdiDi>B-15061002300019</basicUdiDi>
    <tradeName>VISITECT</tradeName>
    <deviceName>VISITECT® CD4 Advanced Disease</deviceName>
    <manufacturerName>AccuBio Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000041152</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080106</emdnCode>
    <emdnDescription>ANTIBODIES FOR LYMPHOCYTE SUBTYPING</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>AB376</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:33:29.670Z</lastUpdated>
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  <row>
    <udiDi>00382903371860</udiDi>
    <basicUdiDi>038290BDTSKYDT9X</basicUdiDi>
    <tradeName>Not Applicable</tradeName>
    <deviceName></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>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>337186</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:27:36.787Z</lastUpdated>
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  <row>
    <udiDi>00382903410118</udiDi>
    <basicUdiDi>038290IPDFTPLRAP</basicUdiDi>
    <tradeName>Not Applicable</tradeName>
    <deviceName></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>
    <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>341011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:27:36.708Z</lastUpdated>
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  <row>
    <udiDi>00382903410248</udiDi>
    <basicUdiDi>038290AGGQCTDV2K</basicUdiDi>
    <tradeName>Not Applicable</tradeName>
    <deviceName></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>
    <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>341024</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:27:36.677Z</lastUpdated>
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  <row>
    <udiDi>00382903457960</udiDi>
    <basicUdiDi>038290IPDFTPLRAP</basicUdiDi>
    <tradeName>Not Applicable</tradeName>
    <deviceName></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>
    <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>345796</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:27:36.508Z</lastUpdated>
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  <row>
    <udiDi>00382903474042</udiDi>
    <basicUdiDi>038290AGGQCTDV2K</basicUdiDi>
    <tradeName>Not Applicable</tradeName>
    <deviceName></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>
    <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>347404</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:27:36.431Z</lastUpdated>
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  <row>
    <udiDi>00382903474059</udiDi>
    <basicUdiDi>038290AGGQCTDV2K</basicUdiDi>
    <tradeName>Not Applicable</tradeName>
    <deviceName></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>
    <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>347405</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:27:36.413Z</lastUpdated>
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  <row>
    <udiDi>00382906666741</udiDi>
    <basicUdiDi>038290BDTSKYDT9X</basicUdiDi>
    <tradeName>Horizon</tradeName>
    <deviceName></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>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>666674</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:18:03.425Z</lastUpdated>
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  <row>
    <udiDi>00382906666758</udiDi>
    <basicUdiDi>038290BDTSKYDT9X</basicUdiDi>
    <tradeName>Horizon</tradeName>
    <deviceName></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>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>666675</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:18:03.370Z</lastUpdated>
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  <row>
    <udiDi>06972825503339</udiDi>
    <basicUdiDi>B-06972825503339</basicUdiDi>
    <tradeName>06972825503339</tradeName>
    <deviceName>CD45</deviceName>
    <manufacturerName>Shenzhen Wellgrow Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022880</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>422201E</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:07:06.217Z</lastUpdated>
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  <row>
    <udiDi>06972825503025</udiDi>
    <basicUdiDi>B-06972825503025</basicUdiDi>
    <tradeName>Wellgrow</tradeName>
    <deviceName>CD45</deviceName>
    <manufacturerName>Shenzhen Wellgrow Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022880</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>422001E</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:07:05.433Z</lastUpdated>
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    <udiDi>06972825502653</udiDi>
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    <tradeName>06972825502653</tradeName>
    <deviceName>CD45</deviceName>
    <manufacturerName>Shenzhen Wellgrow Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022880</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>421901E</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:07:01.423Z</lastUpdated>
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    <udiDi>06972825502141</udiDi>
    <basicUdiDi>B-06972825502141</basicUdiDi>
    <tradeName>CD62P PE</tradeName>
    <deviceName>CD62P PE</deviceName>
    <manufacturerName>Shenzhen Wellgrow Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022880</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50T/Kit, 100T/Kit, 25T/Kit, 96T/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:07:00.608Z</lastUpdated>
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  <row>
    <udiDi>06972825500024</udiDi>
    <basicUdiDi>B-06972825500024</basicUdiDi>
    <tradeName>CD3 FITC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Wellgrow Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022880</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50T/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:06:59.806Z</lastUpdated>
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    <basicUdiDi>B-06971042228872</basicUdiDi>
    <tradeName>Leukemia MLL-ENL Fusion Gene Real Time RT-PCR Kit</tradeName>
    <deviceName>Leukemia MLL-ENL Fusion Gene Real Time RT-PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080105</emdnCode>
    <emdnDescription>ANTIBODIES FOR SUBTYPING OF LEUKEMIA (EXCEPT B-&amp;T-CELL TYPING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TR-0298-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:02:35.991Z</lastUpdated>
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    <udiDi>06971042228865</udiDi>
    <basicUdiDi>B-06971042228865</basicUdiDi>
    <tradeName>Leukemia Gene JAK2 V617F Mutation Real Time RT-PCR Kit</tradeName>
    <deviceName>Leukemia Gene JAK2 V617F Mutation Real Time RT-PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080105</emdnCode>
    <emdnDescription>ANTIBODIES FOR SUBTYPING OF LEUKEMIA (EXCEPT B-&amp;T-CELL TYPING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TR-0297-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:02:34.498Z</lastUpdated>
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