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    <tradeName>HbA1c  35mL</tradeName>
    <deviceName>HbA1c Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>B24176</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:34:06.098Z</lastUpdated>
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    <udiDi>08683555613608</udiDi>
    <basicUdiDi>B-08683555613608</basicUdiDi>
    <tradeName>HbA1c  84mL</tradeName>
    <deviceName>HbA1c Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
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    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:34:05.290Z</lastUpdated>
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    <udiDi>08683555612823</udiDi>
    <basicUdiDi>B-08683555612823</basicUdiDi>
    <tradeName>HbA1c+LYS Kit</tradeName>
    <deviceName>HbA1c+LYS Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:32:04.291Z</lastUpdated>
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    <udiDi>08683555612816</udiDi>
    <basicUdiDi>B-08683555612816</basicUdiDi>
    <tradeName>HbA1c+LYS 72mL</tradeName>
    <deviceName>HbA1c+LYS Kit 72mL</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B27176</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:32:03.500Z</lastUpdated>
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    <udiDi>08683555612809</udiDi>
    <basicUdiDi>B-08683555612809</basicUdiDi>
    <tradeName>HbA1c+LYS</tradeName>
    <deviceName>HbA1c+LYSE Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B27175</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:32:02.684Z</lastUpdated>
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    <udiDi>08683555612090</udiDi>
    <basicUdiDi>B-08683555612090</basicUdiDi>
    <tradeName>HbA1c+Lyse (1x54 + 1x18)</tradeName>
    <deviceName>HbA1c Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B22175</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:29:55.306Z</lastUpdated>
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    <udiDi>08683555601599</udiDi>
    <basicUdiDi>B-08683555601599</basicUdiDi>
    <tradeName>HbA1c Kit</tradeName>
    <deviceName>HbA1c Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B33176</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:23:32.327Z</lastUpdated>
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    <udiDi>06979878281214</udiDi>
    <basicUdiDi>B-06979878281214</basicUdiDi>
    <tradeName>06979878281214</tradeName>
    <deviceName>Glycosylated Hemoglobin (HbA1c) Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Huzhou Jierunxin Biotechnology Co., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000047637</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001051</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:50:34.600Z</lastUpdated>
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    <udiDi>06978139075814</udiDi>
    <basicUdiDi>B-06978139075814</basicUdiDi>
    <tradeName>HbA1c Assay Kits (Lateral Flow Immunoassay)</tradeName>
    <deviceName>HbA1c Assay Kits (Lateral Flow Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>745011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:40:09.905Z</lastUpdated>
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    <udiDi>06976753475089</udiDi>
    <basicUdiDi>B-06976753475089</basicUdiDi>
    <tradeName>HbA1C Rapid Test Device (whole blood)</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>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K020901D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:59:36.226Z</lastUpdated>
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    <udiDi>06976753472637</udiDi>
    <basicUdiDi>B-06976753472637</basicUdiDi>
    <tradeName>HbA1C Rapid Test Strip (whole blood)</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>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K010901D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:58:02.499Z</lastUpdated>
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    <udiDi>06975984067704</udiDi>
    <basicUdiDi>B-06975984067704</basicUdiDi>
    <tradeName>HbA1c Assay Kits (Lateral Flow Immunoassay)</tradeName>
    <deviceName>HbA1c Assay Kits (Lateral Flow Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320301103</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:22:57.314Z</lastUpdated>
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    <udiDi>06975984067698</udiDi>
    <basicUdiDi>B-06975984067698</basicUdiDi>
    <tradeName>HbA1c Assay Kits (Lateral Flow Immunoassay)</tradeName>
    <deviceName>HbA1c Assay Kits (Lateral Flow Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320301102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:22:55.822Z</lastUpdated>
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    <udiDi>06975984067681</udiDi>
    <basicUdiDi>B-06975984067681</basicUdiDi>
    <tradeName>HbA1c Assay Kits (Lateral Flow Immunoassay)</tradeName>
    <deviceName>HbA1c Assay Kits (Lateral Flow Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320301101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:22:38.005Z</lastUpdated>
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    <udiDi>06974674891759</udiDi>
    <basicUdiDi>B-06974674891759</basicUdiDi>
    <tradeName>Glycosylated Hemoglobin (HbA1c) Detection Kit(Fluorescence Immunoassay)</tradeName>
    <deviceName>Glycosylated Hemoglobin (HbA1c) Detection Kit(Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0122</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:12:13.559Z</lastUpdated>
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    <udiDi>06973316741940</udiDi>
    <basicUdiDi>B-06973316741940</basicUdiDi>
    <tradeName>06973316741940</tradeName>
    <deviceName>Glycosylated hemoglobin A1c (HbA1c) Rapid Test Kit(Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Diasia Biomedical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010281</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R331023</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:04:23.143Z</lastUpdated>
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    <udiDi>06973316741933</udiDi>
    <basicUdiDi>B-06973316741933</basicUdiDi>
    <tradeName>06973316741933</tradeName>
    <deviceName>Glycosylated hemoglobin A1c (HbA1c) Rapid Test Kit(Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Diasia Biomedical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010281</manufacturerSrn>
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    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R331022</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:04:22.354Z</lastUpdated>
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    <deviceName>Glycosylated hemoglobin A1c (HbA1c) Rapid Test Kit(Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Diasia Biomedical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010281</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:04:20.740Z</lastUpdated>
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    <tradeName>06973316741919</tradeName>
    <deviceName>Glycosylated hemoglobin A1c (HbA1c) Rapid Test Kit(Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Diasia Biomedical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010281</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R331020</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:04:18.338Z</lastUpdated>
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    <tradeName>06971763225587</tradeName>
    <deviceName>HbA1C Test Kit (Dry Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Lansion Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001086</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0042-03</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:47:15.772Z</lastUpdated>
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