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    <tradeName>Glycated Hemoglobin A1c (HbA1c) Test Kit (Quantum Dots Fluorescence Immunochromatography)</tradeName>
    <deviceName>Glycated Hemoglobin A1c (HbA1c) Test Kit (Quantum Dots Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H7402CL</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:41:15.682Z</lastUpdated>
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    <udiDi>06978896415670</udiDi>
    <basicUdiDi>B-06978896415670</basicUdiDi>
    <tradeName>06978896415670</tradeName>
    <deviceName>Hemoglobin A1C (HbA1c) Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-HbA1c-40</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:48:51.792Z</lastUpdated>
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    <udiDi>06978896415663</udiDi>
    <basicUdiDi>B-06978896415663</basicUdiDi>
    <tradeName>06978896415663</tradeName>
    <deviceName>Hemoglobin A1C (HbA1c) Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-HbA1c-20</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:48:51.000Z</lastUpdated>
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    <udiDi>06978198482011</udiDi>
    <basicUdiDi>B-06978198482011</basicUdiDi>
    <tradeName>Glycosylated Hemoglobin (HbA1c) Test Kit (Immunofluorescence)</tradeName>
    <deviceName>Glycosylated Hemoglobin (HbA1c) Test Kit (Immunofluorescence)</deviceName>
    <manufacturerName>Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046524</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:42:11.691Z</lastUpdated>
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    <udiDi>06977565585539</udiDi>
    <basicUdiDi>B-06977565585539</basicUdiDi>
    <tradeName>Glycohemoglobin A 1C  Kit(Latex Enhanced Immunoturbidimetric Assay)</tradeName>
    <deviceName>Glycohemoglobin A 1C  Kit(Latex Enhanced Immunoturbidimetric Assay)</deviceName>
    <manufacturerName>Coei Biotech Co.Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049509</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5532</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:23:02.977Z</lastUpdated>
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    <udiDi>06977565581142</udiDi>
    <basicUdiDi>B-06977565581142</basicUdiDi>
    <tradeName>HbA1c Rapid Quantitative Test</tradeName>
    <deviceName>HbA1c Rapid Quantitative Test</deviceName>
    <manufacturerName>Coei Biotech Co.Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049509</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1142</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:21:26.803Z</lastUpdated>
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    <udiDi>06977125152393</udiDi>
    <basicUdiDi>B-06977125152393</basicUdiDi>
    <tradeName>HbA1c Assay Kit (HPLC)</tradeName>
    <deviceName>HbA1c Assay Kit (HPLC)</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GHB200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:11:15.457Z</lastUpdated>
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    <udiDi>06977125152386</udiDi>
    <basicUdiDi>B-06977125152386</basicUdiDi>
    <tradeName>HbA1c Assay Kit (HPLC)</tradeName>
    <deviceName>HbA1c Assay Kit (HPLC)</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GHB100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:11:14.611Z</lastUpdated>
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    <udiDi>06976753472293</udiDi>
    <basicUdiDi>B-06976753472293</basicUdiDi>
    <tradeName>HbA1c Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KN001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:57:34.426Z</lastUpdated>
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    <udiDi>06975679490503</udiDi>
    <basicUdiDi>B-06975679490503</basicUdiDi>
    <tradeName>HbA1c Rapid Quantitative Test</tradeName>
    <deviceName>HbA1c Rapid Quantitative Test</deviceName>
    <manufacturerName>Hunan Ehome Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045177</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HbA1c</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:41:24.416Z</lastUpdated>
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    <udiDi>06974854621619</udiDi>
    <basicUdiDi>B-06974854621619</basicUdiDi>
    <tradeName>Glycated Hemoglobin (HbA1C) Test</tradeName>
    <deviceName>Glycated Hemoglobin (HbA1C) Test</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2210625</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:57:48.847Z</lastUpdated>
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    <udiDi>06974738204969</udiDi>
    <basicUdiDi>B-06974738204969</basicUdiDi>
    <tradeName>Glycosylated Hemoglobin Rapid Test Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Fluorescence Immunochromatography Analyzer</deviceName>
    <manufacturerName>Hoyotek Biomedical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003570</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF06-01-20</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:37:27.106Z</lastUpdated>
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    <udiDi>06974738204952</udiDi>
    <basicUdiDi>B-06974738204952</basicUdiDi>
    <tradeName>Glycosylated Hemoglobin Rapid Test Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Fluorescence Immunochromatography Analyzer</deviceName>
    <manufacturerName>Hoyotek Biomedical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003570</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF06-01-20</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:37:26.307Z</lastUpdated>
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    <udiDi>06974521001485</udiDi>
    <basicUdiDi>B-06974521001485</basicUdiDi>
    <tradeName>HbA1c Assay kit CLIA</tradeName>
    <deviceName>HbA1c Assay kit CLIA</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM081072</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:30:25.715Z</lastUpdated>
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    <udiDi>06974521001478</udiDi>
    <basicUdiDi>B-06974521001478</basicUdiDi>
    <tradeName>HbA1c Assay kit CLIA</tradeName>
    <deviceName>HbA1c Assay kit CLIA</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM081036</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:30:24.919Z</lastUpdated>
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    <udiDi>06974521000648</udiDi>
    <basicUdiDi>B-06974521000648</basicUdiDi>
    <tradeName>Diagnostic Kit for HbA1c (Time-resolved Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Diagnostic Kit for HbA1c (Time-resolved Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPF024025</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:27:33.442Z</lastUpdated>
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    <udiDi>06974323013303</udiDi>
    <basicUdiDi>B-06974323013303</basicUdiDi>
    <tradeName>06974323013303</tradeName>
    <deviceName>HbA1c rapid test cassette (Rare earth nano fluorescence immunochromatography)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:53:23.480Z</lastUpdated>
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    <basicUdiDi>B-06974323013297</basicUdiDi>
    <tradeName>06974323013297</tradeName>
    <deviceName>HbA1c rapid test cassette (Rare earth nano fluorescence immunochromatography)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:53:19.479Z</lastUpdated>
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    <basicUdiDi>B-06974323013280</basicUdiDi>
    <tradeName>06974323013280</tradeName>
    <deviceName>HbA1c rapid test cassette (Rare earth nano fluorescence immunochromatography)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:53:18.967Z</lastUpdated>
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    <udiDi>06973315736992</udiDi>
    <basicUdiDi>B-06973315736992</basicUdiDi>
    <tradeName>Glycated Hemoglobin A1c (HbA1c) Test Kit (Quantum Dots Fluorescence Immunochromatography)</tradeName>
    <deviceName>Glycated Hemoglobin A1c (HbA1c) Test Kit (Quantum Dots Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H7403CV</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:02:10.138Z</lastUpdated>
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