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    <tradeName>IMMULITE 2000 Unconjugated Estriol</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
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    <udiDi>08800026300106</udiDi>
    <basicUdiDi>B-08800026300106</basicUdiDi>
    <tradeName>08800026300106</tradeName>
    <deviceName>Exdia β-hCG</deviceName>
    <manufacturerName>Precision Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000034861</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PR-FC10</reference>
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    <lastUpdated>2026-07-09T17:52:30.884Z</lastUpdated>
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    <udiDi>08683548250803</udiDi>
    <basicUdiDi>B-08683548250803</basicUdiDi>
    <tradeName>RapidFor™ AMH Rapid Test Kit (FIA)</tradeName>
    <deviceName>AMH Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-08T21:10:40.360Z</lastUpdated>
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    <udiDi>08683548250261</udiDi>
    <basicUdiDi>B-08683548250261</basicUdiDi>
    <tradeName>RapidFor™ β-HCG (FIA)</tradeName>
    <deviceName>β-HCG  (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:09:34.638Z</lastUpdated>
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    <udiDi>08050593875211</udiDi>
    <basicUdiDi>B-08050593875211</basicUdiDi>
    <tradeName>EUROSPITAL - TEST DI GRAVIDANZA IN AUTODIAGNOSI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Logiter One Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000037076</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TGLOG-14</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:10:13.752Z</lastUpdated>
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    <udiDi>08050593875204</udiDi>
    <basicUdiDi>B-08050593875204</basicUdiDi>
    <tradeName>TEST DI GRAVIDANZA  - PROTEC 1PZ</tradeName>
    <deviceName>TEST DI GRAVIDANZA PROTEC 1 PZ</deviceName>
    <manufacturerName>Logiter One Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000037076</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TESTG001BH</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:10:12.153Z</lastUpdated>
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    <udiDi>08050593875105</udiDi>
    <basicUdiDi>B-08050593875105</basicUdiDi>
    <tradeName>TEST DI GRAVIDANZA</tradeName>
    <deviceName>TEST DI GRAVIDANZA</deviceName>
    <manufacturerName>Logiter One Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000037076</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:10:11.359Z</lastUpdated>
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    <udiDi>08050593875013</udiDi>
    <basicUdiDi>B-08050593875013</basicUdiDi>
    <tradeName>FREETOUCH - 2 PZ</tradeName>
    <deviceName>TEST DI GRAVIDANZA IN AUTODIAGNOSI</deviceName>
    <manufacturerName>Logiter One Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000037076</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:10:09.758Z</lastUpdated>
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    <udiDi>08034049110149</udiDi>
    <basicUdiDi>B-08034049110149</basicUdiDi>
    <tradeName>08034049110149</tradeName>
    <deviceName>b-HCG ELISA</deviceName>
    <manufacturerName>Dia.Metra Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000027206</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050213</emdnCode>
    <emdnDescription>FREE BETA HCG (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DKO014</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:01:17.792Z</lastUpdated>
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    <udiDi>06980070460055</udiDi>
    <basicUdiDi>B-06980070460055</basicUdiDi>
    <tradeName>Sharay Anti-Trophoblast Cell Membrane (CLIA)</tradeName>
    <deviceName>Sharay Anti-Trophoblast Cell Membrane (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050299</emdnCode>
    <emdnDescription>PREGNANCY TESTING HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000777</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:53:08.108Z</lastUpdated>
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    <udiDi>06980070460048</udiDi>
    <basicUdiDi>B-06980070460048</basicUdiDi>
    <tradeName>Sharay Anti-hCG IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-hCG IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050299</emdnCode>
    <emdnDescription>PREGNANCY TESTING HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000778</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:53:07.293Z</lastUpdated>
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    <udiDi>06979878281115</udiDi>
    <basicUdiDi>B-06979878281115</basicUdiDi>
    <tradeName>06979878281115</tradeName>
    <deviceName>Anti-Muellerian Hormone Test (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Huzhou Jierunxin Biotechnology Co., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000047637</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001047</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:50:19.623Z</lastUpdated>
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    <udiDi>06979878281122</udiDi>
    <basicUdiDi>B-06979878281122</basicUdiDi>
    <tradeName>06979878281122</tradeName>
    <deviceName>Beta-subunit of Human Chorionic Gonadotropin Test (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Huzhou Jierunxin Biotechnology Co., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000047637</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001048</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:50:19.618Z</lastUpdated>
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    <udiDi>06979469761552</udiDi>
    <basicUdiDi>B-06979469761552</basicUdiDi>
    <tradeName>Beta Human Chorionic Gonadotropin Test Kit</tradeName>
    <deviceName>Beta Human Chorionic Gonadotropin Test Kit</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G1404CC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:44:05.374Z</lastUpdated>
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    <udiDi>06979469761569</udiDi>
    <basicUdiDi>B-06979469761569</basicUdiDi>
    <tradeName>Beta Human Chorionic Gonadotropin Test Kit</tradeName>
    <deviceName>Beta Human Chorionic Gonadotropin Test Kit</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G1403CC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:44:03.776Z</lastUpdated>
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    <udiDi>06979469761545</udiDi>
    <basicUdiDi>B-06979469761545</basicUdiDi>
    <tradeName>Beta Human Chorionic Gonadotropin Test Kit</tradeName>
    <deviceName>Beta Human Chorionic Gonadotropin Test Kit</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G1402CC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:44:02.980Z</lastUpdated>
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    <udiDi>06979469761538</udiDi>
    <basicUdiDi>B-06979469761538</basicUdiDi>
    <tradeName>Beta Human Chorionic Gonadotropin Test Kit</tradeName>
    <deviceName>Beta Human Chorionic Gonadotropin Test Kit</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G1403CV</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:43:47.613Z</lastUpdated>
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    <basicUdiDi>B-06979355926294</basicUdiDi>
    <tradeName>06979355926294</tradeName>
    <deviceName>β-Human Chorionic Gonadotropin (β-HCG) Quantitative Test Kit (Chemiluminescent Immunoassay,CLIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests/kit (including calibration and control)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:24:05.773Z</lastUpdated>
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    <tradeName>06979355926300</tradeName>
    <deviceName>β-Human Chorionic Gonadotropin (β-HCG) Quantitative Test Kit (Chemiluminescent Immunoassay,CLIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit (including calibration and control)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:24:03.362Z</lastUpdated>
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    <tradeName>06979355926270</tradeName>
    <deviceName>β-Human Chorionic Gonadotropin (β-HCG) Quantitative Test Kit (Chemiluminescent Immunoassay,CLIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
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    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit (including control)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:24:01.800Z</lastUpdated>
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