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    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
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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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    <deviceName>Beta-Thalassemia Analysis  Kits ( HPLC )</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
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    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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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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    <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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    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
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    <deviceName>Beta-Thalassemia Analysis  Kits ( HPLC )</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
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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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    <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>
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    <emdnCode>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:37:30.433Z</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>
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    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <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>
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    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <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>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:37:24.018Z</lastUpdated>
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    <udiDi>06975417760066</udiDi>
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    <tradeName>Glycosylated Hemoglobin test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Glycosylated Hemoglobin test (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Hotgen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015566</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
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    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGCL59</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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