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    <deviceName>Beta-Thalassemia Analysis  Kits ( HPLC )</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
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    <lastUpdated>2026-07-06T20:37:48.173Z</lastUpdated>
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    <deviceName>Beta-Thalassemia Analysis  Kits ( HPLC )</deviceName>
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    <deviceName>Beta-Thalassemia Analysis  Kits ( HPLC )</deviceName>
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    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
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    <deviceName>Beta-Thalassemia Analysis  Kits ( HPLC )</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
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    <lastUpdated>2026-07-06T20:37:28.830Z</lastUpdated>
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    <deviceName>Beta-Thalassemia Analysis  Kits ( HPLC )</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
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    <deviceName>Beta-Thalassemia Analysis  Kits ( HPLC )</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
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    <tradeName>HbA1c Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>HbA1c Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
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    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL233701C</reference>
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    <lastUpdated>2026-07-06T19:43:11.726Z</lastUpdated>
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    <deviceName>HbA1c Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T19:40:19.382Z</lastUpdated>
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    <tradeName>HbA1c Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>HbA1c Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010299</emdnCode>
    <emdnDescription>OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20T</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:36:52.726Z</lastUpdated>
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    <tradeName>Hemoglobin A1c (HbA1c) Rapid Test Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Hemoglobin A1c (HbA1c) Rapid Test Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Guangzhou Decheng Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013536</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010299</emdnCode>
    <emdnDescription>OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5257C4X025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:09:01.307Z</lastUpdated>
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    <deviceName>HEMDETECT®50 x 3 TRISLIDES</deviceName>
    <manufacturerName>DIPRO med GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024589</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-03T20:50:45.824Z</lastUpdated>
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    <manufacturerName>DIPRO med GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024589</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:50:44.455Z</lastUpdated>
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    <tradeName>HbChek</tradeName>
    <deviceName>Hemoglobin Microcuvette / Test Strips - A Reagent less Specimen Receptacle</deviceName>
    <manufacturerName>Biosense Technologies Private Limited.</manufacturerName>
    <manufacturerSrn>IN-MF-000052180</manufacturerSrn>
    <authorisedRepresentativeName>MD&amp;D Alliance GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045389</authorisedRepresentativeSrn>
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    <emdnDescription>HAEMOGLOBIN DETERMINATIONS (TOTAL HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-03T19:07:25.462Z</lastUpdated>
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    <tradeName>DRABKIN ROZTOK</tradeName>
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    <lastUpdated>2026-07-03T13:54:23.707Z</lastUpdated>
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    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
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    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
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    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
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    <emdnDescription>OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER</emdnDescription>
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    <tradeName>HbA1c Eluent</tradeName>
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    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
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    <emdnDescription>OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XQ-0105-02</reference>
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    <lastUpdated>2026-07-02T08:26:59.158Z</lastUpdated>
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