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    <basicUdiDi>150995905IM34926F</basicUdiDi>
    <tradeName>Ferritin IRMA KIT</tradeName>
    <deviceName>Ferritin IRMA KIT</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM3492</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:45:25.663Z</lastUpdated>
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    <udiDi>15099590209308</udiDi>
    <basicUdiDi>150995901AccFolSH</basicUdiDi>
    <tradeName>Access Folate Reagent Pack</tradeName>
    <deviceName>Access Folate Reagent Pack</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>IVDR 2017/746</legislation>
    <emdnCode>W0102070103</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>A98032</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:32:54.792Z</lastUpdated>
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    <udiDi>15099590202811</udiDi>
    <basicUdiDi>150995901AccsTfRDQ</basicUdiDi>
    <tradeName>Access sTFR Reagent Pack</tradeName>
    <deviceName>Access sTFR Reagent Pack</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>SOLUBLE TRANSFERRIN RECEPTOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A32493</reference>
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    <lastUpdated>2026-07-30T17:32:16.433Z</lastUpdated>
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    <udiDi>15099590201838</udiDi>
    <basicUdiDi>150995901AccEPONE</basicUdiDi>
    <tradeName>Access EPO (Reagent Pack)</tradeName>
    <deviceName>Access EPO (Reagent Pack)</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>W0102070101</emdnCode>
    <emdnDescription>ERYTHROPOIETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16364</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:32:06.725Z</lastUpdated>
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    <udiDi>15099590201685</udiDi>
    <basicUdiDi>150995901AccFolLysAg79</basicUdiDi>
    <tradeName>Access Red Blood Cell Folate Lysing Agent</tradeName>
    <deviceName>Access Red Blood Cell Folate Lysing Agent</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A14206</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:32:05.938Z</lastUpdated>
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    <udiDi>15099590223373</udiDi>
    <basicUdiDi>150995901447160KU</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems FER Ferritin Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems FER Ferritin Reagent</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447160</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:24:55.580Z</lastUpdated>
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    <udiDi>D-CNMF000014455-BF-S133RK</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S133RK</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S133RK</tradeName>
    <deviceName>Ferritin Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S133</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-28T13:19:20.309Z</lastUpdated>
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    <udiDi>06971348762681</udiDi>
    <basicUdiDi>697134876012B2681XA</basicUdiDi>
    <tradeName>Ferritin (FERR) Diagnostic Kit (Immunochromatographic Assay)</tradeName>
    <deviceName>Ferritin (FERR) Diagnostic Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-012-20</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-26T03:50:28.704Z</lastUpdated>
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  <row>
    <udiDi>06971348764562</udiDi>
    <basicUdiDi>697134876012B2681XA</basicUdiDi>
    <tradeName>Ferritin (FERR) Diagnostic Kit (Immunochromatographic Assay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-012-25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T03:48:39.905Z</lastUpdated>
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  <row>
    <udiDi>06933289852111</udiDi>
    <basicUdiDi>B-06933289852111</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Folate (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA18P0005</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:52:31.646Z</lastUpdated>
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    <udiDi>06933289852104</udiDi>
    <basicUdiDi>B-06933289852104</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Folate (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA18P0004</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:52:27.647Z</lastUpdated>
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    <udiDi>06933289852098</udiDi>
    <basicUdiDi>B-06933289852098</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Folate (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA18P0003</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:52:26.843Z</lastUpdated>
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  <row>
    <udiDi>06933289852081</udiDi>
    <basicUdiDi>B-06933289852081</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Folate (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA18P0002</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:52:26.046Z</lastUpdated>
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    <udiDi>06933289852715</udiDi>
    <basicUdiDi>B-06933289852715</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Ferritin (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA46P0005</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-24T21:47:40.986Z</lastUpdated>
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    <udiDi>06933289852708</udiDi>
    <basicUdiDi>B-06933289852708</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Ferritin (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA46P0004</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-24T21:47:36.973Z</lastUpdated>
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    <udiDi>06933289852692</udiDi>
    <basicUdiDi>B-06933289852692</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Ferritin (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA46P0003</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-24T21:47:36.174Z</lastUpdated>
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    <udiDi>06933289852685</udiDi>
    <basicUdiDi>B-06933289852685</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Ferritin (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA46P0002</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-24T21:47:35.437Z</lastUpdated>
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    <udiDi>84352873305044</udiDi>
    <basicUdiDi>B-84352873305044</basicUdiDi>
    <tradeName>Clonatest</tradeName>
    <deviceName>Ferritin-Turbidimetric</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR31600</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:40:59.422Z</lastUpdated>
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    <udiDi>84352873305051</udiDi>
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    <tradeName>Clonatest</tradeName>
    <deviceName>Ferritin-Turbidimetric</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR31602</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:40:58.512Z</lastUpdated>
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    <udiDi>84352873305037</udiDi>
    <basicUdiDi>B-84352873305037</basicUdiDi>
    <tradeName>Clonatest</tradeName>
    <deviceName>Ferritin-Turbidimetric</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CT31602</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:40:54.530Z</lastUpdated>
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