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    <lastUpdated>2026-09-29T12:15:13.288Z</lastUpdated>
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    <tradeName>AFP CLIA</tradeName>
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    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
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    <tradeName>ACTH CLIA</tradeName>
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    <tradeName>ACTH CLIA</tradeName>
    <deviceName>ACTH CLIA</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
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    <tradeName>ACTH CLIA</tradeName>
    <deviceName>ACTH CLIA</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
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    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
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    <emdnDescription>ALDOSTERONE</emdnDescription>
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    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:14:43.923Z</lastUpdated>
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    <basicUdiDi>B-06942609200020</basicUdiDi>
    <tradeName>ALD CLIA</tradeName>
    <deviceName>ALD CLIA</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>ALD CLIA</tradeName>
    <deviceName>ALD CLIA</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <emdnDescription>ALDOSTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAD78K5N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:14:22.902Z</lastUpdated>
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    <tradeName>ALD CLIA</tradeName>
    <deviceName>ALD CLIA</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W0102060201</emdnCode>
    <emdnDescription>ALDOSTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAD78K0N</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-29T12:14:18.821Z</lastUpdated>
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    <tradeName>Fully automatic chemiluminescence immunoassay analyzer</tradeName>
    <deviceName>Fully automatic chemiluminescence immunoassay analyzer</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2FF00003</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-24T11:13:34.391Z</lastUpdated>
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    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GFQXY31Q</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-24T11:13:30.713Z</lastUpdated>
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    <tradeName>Dry immunoassay analyzer</tradeName>
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    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-24T11:13:19.187Z</lastUpdated>
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    <tradeName>Fully automatic chemiluminescence immunoassay analyzer</tradeName>
    <deviceName>Fully automatic chemiluminescence immunoassay analyzer</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <placedOnMarketCountry>Romania</placedOnMarketCountry>
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    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
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    <reference>GFQXY00A</reference>
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    <tradeName>Dry immunoassay analyzer</tradeName>
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    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
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    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
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    <tradeName>Substrate Solution</tradeName>
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    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
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    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
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    <tradeName>Fully automatic chemiluminescence immunoassay analyzer</tradeName>
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    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
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    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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