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    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
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    <reference>HR0522002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:16:18.349Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160301</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0522001</reference>
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    <udiDi>06977194141755</udiDi>
    <basicUdiDi>B-06977194141755</basicUdiDi>
    <tradeName>06977194141755</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0202501</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:12:31.239Z</lastUpdated>
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    <tradeName>06975260988631</tradeName>
    <deviceName>FSH 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>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0034-03</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:26:12.728Z</lastUpdated>
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    <tradeName>Follicle Stimulating Hormone (FSH) Detection Kit(Fluorescence Immunoassay)</tradeName>
    <deviceName>Follicle Stimulating Hormone (FSH) 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>
    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0104</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:11:27.864Z</lastUpdated>
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    <deviceName>ollicle-stimulating Hormone (FSH) Rapid Test Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA2229</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:22.147Z</lastUpdated>
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    <deviceName>Follicle-stimulating Hormone (FSH) Rapid Test Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA2229</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:21.344Z</lastUpdated>
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    <deviceName>Follicle-stimulating Hormone (FSH) Rapid Test Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA2229</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:19.750Z</lastUpdated>
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    <udiDi>06973841001144</udiDi>
    <basicUdiDi>B-06973841001144</basicUdiDi>
    <tradeName>Follicle Stimulating Hormone Test Kit (Immunofluorescence)</tradeName>
    <deviceName>Follicle Stimulating Hormone Test Kit (Immunofluorescence)</deviceName>
    <manufacturerName>Guangdong Wesail Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008828</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA0380</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:39:28.850Z</lastUpdated>
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    <udiDi>06973316742343</udiDi>
    <basicUdiDi>B-06973316742343</basicUdiDi>
    <tradeName>06973316742343</tradeName>
    <deviceName>Follicle-stimulating Hormone (FSH) Fluorescence ImmunoAssay (FIA) Test</deviceName>
    <manufacturerName>Diasia Biomedical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010281</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R331083</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:06:34.980Z</lastUpdated>
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    <deviceName>Follicle-stimulating Hormone (FSH) Fluorescence ImmunoAssay (FIA) Test</deviceName>
    <manufacturerName>Diasia Biomedical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010281</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R331082</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:06:34.164Z</lastUpdated>
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    <deviceName>Follicle-stimulating Hormone (FSH) Fluorescence ImmunoAssay (FIA) Test</deviceName>
    <manufacturerName>Diasia Biomedical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010281</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R331081</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:06:33.362Z</lastUpdated>
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    <deviceName>Follicle-stimulating Hormone (FSH) Fluorescence ImmunoAssay (FIA) Test</deviceName>
    <manufacturerName>Diasia Biomedical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010281</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R331080</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:06:29.464Z</lastUpdated>
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    <basicUdiDi>B-06952804837051</basicUdiDi>
    <tradeName>06952804837051</tradeName>
    <deviceName>Free Human Chorionic Gonadotropin Chemiluminescence Immunoassay Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G008A08X</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:32:46.296Z</lastUpdated>
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    <tradeName>PreventID® Menopause</tradeName>
    <deviceName>PreventID® Menopause</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>KST17114GP</reference>
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    <lastUpdated>2026-07-06T00:50:10.266Z</lastUpdated>
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    <tradeName>PreventID® Menopause</tradeName>
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    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>KST17114G10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:50:09.501Z</lastUpdated>
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    <tradeName>Heltes</tradeName>
    <deviceName>Follicle Stimulating Hormone (FSH) Menopause Test kits for self-testing</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01-04-130HT2</reference>
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    <lastUpdated>2026-07-04T14:23:24.689Z</lastUpdated>
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    <tradeName>fertylia</tradeName>
    <deviceName>Follicle-stimulating hormone (FSH) Tests for Self-Testing</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <emdnCode>W0102160301</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:23:10.269Z</lastUpdated>
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    <tradeName>apotekets</tradeName>
    <deviceName>Follicle Stimulating Hormone (FSH) Tests for self-testing</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
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    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01-04-130AK2</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
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    <tradeName>THE NEW Test Days</tradeName>
    <deviceName>Follicle Stimulating Hormone (FSH) Menopause Test kits for self-testing</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Kendi Kendine Test</riskClass>
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    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01-04-130NTD1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:23:03.867Z</lastUpdated>
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