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    <tradeName>Inhibin B Control</tradeName>
    <deviceName>Inhibin B Control</deviceName>
    <manufacturerName>SHENZHEN EVER-BLUE BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000025048</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>HORMONE CONTROLS</emdnDescription>
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    <reference>ZCC028</reference>
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    <lastUpdated>2026-07-02T12:10:10.337Z</lastUpdated>
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    <tradeName>17α-Hydroxyprogesterone Control</tradeName>
    <deviceName>17α-Hydroxyprogesterone Control</deviceName>
    <manufacturerName>SHENZHEN EVER-BLUE BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000025048</manufacturerSrn>
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    <tradeName>Adiponectin Control</tradeName>
    <deviceName>Adiponectin Control</deviceName>
    <manufacturerName>SHENZHEN EVER-BLUE BIOTECH CO., LTD.</manufacturerName>
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    <tradeName>AMH Control</tradeName>
    <deviceName>AMH Control</deviceName>
    <manufacturerName>SHENZHEN EVER-BLUE BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000025048</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>HORMONE CONTROLS</emdnDescription>
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    <reference>ZCC027</reference>
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    <lastUpdated>2026-07-02T12:09:51.162Z</lastUpdated>
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    <udiDi>06947145586294</udiDi>
    <basicUdiDi>694714551049JA</basicUdiDi>
    <tradeName>MAGLUMI Progesterone (CLIA) Controls</tradeName>
    <deviceName>Progesterone (CLIA) Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1602011049MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:54:08.960Z</lastUpdated>
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    <udiDi>06947145586218</udiDi>
    <basicUdiDi>694714551047J6</basicUdiDi>
    <tradeName>MAGLUMI Testosterone (CLIA) Controls</tradeName>
    <deviceName>Testosterone (CLIA) Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>HORMONE CONTROLS</emdnDescription>
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    <tradeName>MAGLUMI Androstenedione (CLIA) Controls</tradeName>
    <deviceName>Androstenedione (CLIA) Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <tradeName>MAGLUMI Unconjugated Estriol (CLIA) Controls</tradeName>
    <deviceName>Unconjugated Estriol (CLIA) Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>HORMONE CONTROLS</emdnDescription>
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    <reference>160201260MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:52:42.445Z</lastUpdated>
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    <tradeName>MAGLUMI Anti-TM (CLIA) Controls</tradeName>
    <deviceName>Anti-TM (CLIA) Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201248MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:51:49.559Z</lastUpdated>
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    <udiDi>06947145515195</udiDi>
    <basicUdiDi>69471455423W7</basicUdiDi>
    <tradeName>MAGLUMI Androstenedione (CLIA) Controls</tradeName>
    <deviceName>Androstenedione (CLIA) Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201423MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:51:11.090Z</lastUpdated>
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    <udiDi>06947145580841</udiDi>
    <basicUdiDi>694714551042HU</basicUdiDi>
    <tradeName>MAGLUMI Free T4 (CLIA) Controls</tradeName>
    <deviceName>Free T4 (CLIA) Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1602011042MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:48:16.943Z</lastUpdated>
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    <udiDi>06947145580803</udiDi>
    <basicUdiDi>694714551041HS</basicUdiDi>
    <tradeName>MAGLUMI Free T3 (CLIA) Controls</tradeName>
    <deviceName>Free T3 (CLIA) Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1602011041MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:48:16.146Z</lastUpdated>
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    <udiDi>06947145580766</udiDi>
    <basicUdiDi>694714551040HQ</basicUdiDi>
    <tradeName>MAGLUMI Total T4 (CLIA) Controls</tradeName>
    <deviceName>Total T4 (CLIA) Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1602011040MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:48:15.341Z</lastUpdated>
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    <udiDi>06947145580728</udiDi>
    <basicUdiDi>694714551039J7</basicUdiDi>
    <tradeName>MAGLUMI Total T3 (CLIA) Controls</tradeName>
    <deviceName>Total T3 (CLIA) Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>HORMONE CONTROLS</emdnDescription>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:48:14.536Z</lastUpdated>
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    <basicUdiDi>69506174IM449202EZ</basicUdiDi>
    <tradeName>06950617424741</tradeName>
    <deviceName>Hormones Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4497300</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:47:22.828Z</lastUpdated>
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    <deviceName>Hormones Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
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    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4491202</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:47:16.827Z</lastUpdated>
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    <deviceName>Hormones Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4492202</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:44:04.689Z</lastUpdated>
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    <deviceName>Hormones Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
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    <emdnDescription>HORMONE CONTROLS</emdnDescription>
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    <lastUpdated>2026-06-28T05:44:03.487Z</lastUpdated>
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    <deviceName>Hormones Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
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    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4494202</reference>
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    <lastUpdated>2026-06-28T05:43:57.487Z</lastUpdated>
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    <tradeName>06950617404453</tradeName>
    <deviceName>Hormones Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
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    <lastUpdated>2026-06-28T05:43:56.293Z</lastUpdated>
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