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    <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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    <reference>105-005729-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:00:05.301Z</lastUpdated>
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    <tradeName>HLA-B27 Reagent</tradeName>
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    <tradeName>CD3-FITC/CD16+56-PE/CD45-PerCP/CD19-APC Reagent</tradeName>
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    <tradeName>CD3-FITC/CD8-PE/CD45-PerCP/CD4-APC Reagent</tradeName>
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    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
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    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-035033-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:50:07.304Z</lastUpdated>
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    <udiDi>04050598165106</udiDi>
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    <tradeName>Immunglobulin G ELISA</tradeName>
    <deviceName>Immunglobulin G ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>IGA, IGD, IGM, IGG, IGE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6510</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:37.322Z</lastUpdated>
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    <tradeName>Monoclonal Mouse Anti-Human Terminal Deoxynucleotidyl Transferase/APC, Clone DAK-TDT</tradeName>
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    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000014448</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>MONOCLONAL ANTIBODIES FOR RECOGNIZING ENZYMES</emdnDescription>
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    <reference>C1001</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:57:44.510Z</lastUpdated>
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    <tradeName>Polyclonal Goat Anti-Mouse Immunoglobulins/ RPE, Goat F(ab')2</tradeName>
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    <lastUpdated>2026-07-31T08:56:56.391Z</lastUpdated>
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    <tradeName>Polyclonal Rabbit Anti-Mouse Immunoglobulins/ RPE, Rabbit F(ab')2</tradeName>
    <deviceName>Polyclonal Rabbit Anti-Mouse Immunoglobulins/FITC Rabbit F(ab')2</deviceName>
    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0439</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:56:51.480Z</lastUpdated>
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    <udiDi>05700572013693</udiDi>
    <basicUdiDi>570057P3006P3008A054801SD</basicUdiDi>
    <tradeName>EasyLyse Erythrocyte-Lysing Reagent</tradeName>
    <deviceName>EasyLyse Erythrocyte-Lysing Reagent</deviceName>
    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000014448</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>AUXILIARY &amp; SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S2364</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:52:24.202Z</lastUpdated>
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    <udiDi>05700572002857</udiDi>
    <basicUdiDi>570057R0302P3006A017101MD</basicUdiDi>
    <tradeName>Polyclonal Goat Anti-Mouse Immunoglobulins/FITC Goat F(ab')2</tradeName>
    <deviceName>Polyclonal Goat Anti-Mouse Immunoglobulins/FITC Goat F(ab')2</deviceName>
    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000014448</manufacturerSrn>
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    <emdnDescription>AUXILIARY &amp; SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F0479</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:51:52.580Z</lastUpdated>
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    <udiDi>05700572004387</udiDi>
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    <tradeName>IntraStain</tradeName>
    <deviceName>IntraStain</deviceName>
    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000014448</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>W0103080599</emdnCode>
    <emdnDescription>AUXILIARY &amp; SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K2311</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:51:52.579Z</lastUpdated>
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    <tradeName>Polyclonal Rabbit Anti-Mouse Immunoglobulins/FITC Rabbit F(ab')2</tradeName>
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    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
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    <emdnDescription>AUXILIARY &amp; SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F0313</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:51:47.327Z</lastUpdated>
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    <deviceName>T-Cell Xtend</deviceName>
    <manufacturerName>Oxford Immunotec Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004429</manufacturerSrn>
    <authorisedRepresentativeName>Wallac Oy</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FI-AR-000044744</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TTK.610</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:06:13.718Z</lastUpdated>
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    <basicUdiDi>4987562CyFlowCLEANPV</basicUdiDi>
    <tradeName>04987562499328</tradeName>
    <deviceName>CyFlow CLEAN</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CH548734</reference>
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    <lastUpdated>2026-07-31T04:35:59.766Z</lastUpdated>
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    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>AY104869</reference>
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    <lastUpdated>2026-07-31T04:35:58.172Z</lastUpdated>
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    <tradeName>PerFix-nc (no centrifuge assay Kit)</tradeName>
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    <manufacturerName>IMMUNOTECH SAS</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>INTRA</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:46:05.770Z</lastUpdated>
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    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>AUXILIARY &amp; SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER</emdnDescription>
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    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <emdnDescription>STEM CELL ENUMERATION CONTROLS</emdnDescription>
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    <lastUpdated>2026-07-30T17:45:42.504Z</lastUpdated>
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