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    <tradeName>++B261CANDG460ES</tradeName>
    <deviceName>5α-Androstane-3α, 17ß-diol Glucuronide (3α Diol G) ELISA</deviceName>
    <manufacturerName>Diagnostics Biochem Canada Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000032449</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050112</emdnCode>
    <emdnDescription>ANDROSTANEDIOL-GLUCURONIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-DG-460</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:39:56.092Z</lastUpdated>
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    <udiDi>++B261CANAD208CQ</udiDi>
    <basicUdiDi>B-++B261CANAD208CQ</basicUdiDi>
    <tradeName>++B261CANAD208CQ</tradeName>
    <deviceName>Androstenedione ELISA</deviceName>
    <manufacturerName>Diagnostics Biochem Canada Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000032449</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050101</emdnCode>
    <emdnDescription>ANDROSTENEDIONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-AD-208</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:39:24.026Z</lastUpdated>
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    <udiDi>08806133046975</udiDi>
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    <tradeName>AFIAS Total βhCG</tradeName>
    <deviceName>AFIAS Total βhCG</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMFP-3</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:00:53.878Z</lastUpdated>
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    <tradeName>AFIAS Testosterone</tradeName>
    <deviceName>AFIAS Testosterone</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMFP-29</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:00:34.937Z</lastUpdated>
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    <udiDi>08699195610037</udiDi>
    <basicUdiDi>869919561003LBHG.014V</basicUdiDi>
    <tradeName>Laboquick</tradeName>
    <deviceName>Laboquick Pregnancy Cassette Test</deviceName>
    <manufacturerName>Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Ltd. Sti.</manufacturerName>
    <manufacturerSrn>TR-MF-000032257</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050299</emdnCode>
    <emdnDescription>PREGNANCY TESTING HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LBHG.01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:41:38.686Z</lastUpdated>
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    <udiDi>06978139075098</udiDi>
    <basicUdiDi>69703416803205076JU</basicUdiDi>
    <tradeName>free TESTO (eCLIA)</tradeName>
    <deviceName>free TESTO (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</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>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320514702</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:14:22.928Z</lastUpdated>
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    <udiDi>06975984064178</udiDi>
    <basicUdiDi>69703416803205099K8</basicUdiDi>
    <tradeName>Total β-HCG STAT</tradeName>
    <deviceName>Total β-HCG STAT</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</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>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320509301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:14:16.218Z</lastUpdated>
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    <tradeName>PROG STAT (eCLIA)</tradeName>
    <deviceName>PROG STAT (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</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>W0102050106</emdnCode>
    <emdnDescription>PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320510601</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:14:03.433Z</lastUpdated>
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    <udiDi>06975984063690</udiDi>
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    <tradeName>SHBG (eCLIA)</tradeName>
    <deviceName>SHBG (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</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>W0102050109</emdnCode>
    <emdnDescription>SEX HORMONE BINDING GLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320509001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:14:02.941Z</lastUpdated>
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    <udiDi>06936700410105</udiDi>
    <basicUdiDi>6970297531062AF</basicUdiDi>
    <tradeName>Total β Human Chorionic Gonadotropin test (Up-converting Phosphor Technology)</tradeName>
    <deviceName>Total β Human Chorionic Gonadotropin test (Up-converting Phosphor Technology)</deviceName>
    <manufacturerName>Beijing Hotgen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015566</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGUPT38</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:09:45.786Z</lastUpdated>
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    <udiDi>06936700410075</udiDi>
    <basicUdiDi>6970297531059AS</basicUdiDi>
    <tradeName>Follicle-stimulating Hormone test (Up-converting Phosphor Technology)</tradeName>
    <deviceName>Follicle-stimulating Hormone test (Up-converting Phosphor Technology)</deviceName>
    <manufacturerName>Beijing Hotgen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015566</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGUPT35</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:09:44.187Z</lastUpdated>
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    <udiDi>06936700410068</udiDi>
    <basicUdiDi>6970297531058AQ</basicUdiDi>
    <tradeName>Estradiol test (Up-converting Phosphor Technology)</tradeName>
    <deviceName>Estradiol test (Up-converting Phosphor Technology)</deviceName>
    <manufacturerName>Beijing Hotgen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015566</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050103</emdnCode>
    <emdnDescription>ESTRADIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGUPT34</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:09:43.388Z</lastUpdated>
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    <udiDi>06936700410051</udiDi>
    <basicUdiDi>6970297531057AN</basicUdiDi>
    <tradeName>Luteinizing Hormone test (Up-converting Phosphor Technology)</tradeName>
    <deviceName>Luteinizing Hormone test (Up-converting Phosphor Technology)</deviceName>
    <manufacturerName>Beijing Hotgen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015566</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050105</emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGUPT33</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:09:39.376Z</lastUpdated>
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    <udiDi>06936700406740</udiDi>
    <basicUdiDi>697029753301L3</basicUdiDi>
    <tradeName>β-Human Chorionic Gonadotropin test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>β-Human Chorionic Gonadotropin 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>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGCL21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:09:06.855Z</lastUpdated>
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    <tradeName>Testosterone test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Testosterone 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>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGCL19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:08:52.107Z</lastUpdated>
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    <tradeName>Progesterone test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Progesterone 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>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050106</emdnCode>
    <emdnDescription>PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGCL20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:08:44.882Z</lastUpdated>
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    <tradeName>Estradiol test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Estradiol 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>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050103</emdnCode>
    <emdnDescription>ESTRADIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGCL18</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:08:43.301Z</lastUpdated>
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    <basicUdiDi>697029753442LN</basicUdiDi>
    <tradeName>Anti-Mullerian Hormone Test (Up-converting Phosphor Technology)</tradeName>
    <deviceName>Anti-Mullerian Hormone Test (Up-converting Phosphor Technology)</deviceName>
    <manufacturerName>Beijing Hotgen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015566</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGUPT15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:08:18.425Z</lastUpdated>
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    <basicUdiDi>697029753292LT</basicUdiDi>
    <tradeName>Follicle-stimulating Hormone test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Follicle-stimulating Hormone 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>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGCL15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:08:03.213Z</lastUpdated>
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    <basicUdiDi>697029753299M9</basicUdiDi>
    <tradeName>Luteinizing Hormone test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Luteinizing Hormone 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>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050105</emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGCL16</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:08:01.884Z</lastUpdated>
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