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    <tradeName>One Step Pregnancy Test Kit (Colloidal Gold immunochromatographic Assay)</tradeName>
    <deviceName>One Step Pregnancy Test Kit (Colloidal Gold immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Easy-Sweet Bio-medical Science and Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037568</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:23:30.857Z</lastUpdated>
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    <tradeName>One Step Pregnancy Test Kit (Colloidal Gold immunochromatographic Assay)</tradeName>
    <deviceName>One Step Pregnancy Test Kit (Colloidal Gold immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Easy-Sweet Bio-medical Science and Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037568</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <tradeName>One Step Pregnancy Test Kit (Colloidal Gold immunochromatographic Assay)</tradeName>
    <deviceName>One Step Pregnancy Test Kit (Colloidal Gold immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Easy-Sweet Bio-medical Science and Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037568</manufacturerSrn>
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    <tradeName>One Step Pregnancy Test Kit (Colloidal Gold immunochromatographic Assay)</tradeName>
    <deviceName>One Step Pregnancy Test Kit (Colloidal Gold immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Easy-Sweet Bio-medical Science and Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037568</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
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    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:23:25.250Z</lastUpdated>
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    <basicUdiDi>B-06975228760118</basicUdiDi>
    <tradeName>One Step Pregnancy Test Kit (Colloidal Gold immunochromatographic Assay)</tradeName>
    <deviceName>One Step Pregnancy Test Kit (Colloidal Gold immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Easy-Sweet Bio-medical Science and Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037568</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESWT-C-FHC-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:23:24.446Z</lastUpdated>
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    <basicUdiDi>B-06975228760101</basicUdiDi>
    <tradeName>One Step Pregnancy Test Kit (Colloidal Gold immunochromatographic Assay)</tradeName>
    <deviceName>One Step Pregnancy Test Kit (Colloidal Gold immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Easy-Sweet Bio-medical Science and Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037568</manufacturerSrn>
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    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <basicUdiDi>B-06975228760095</basicUdiDi>
    <tradeName>One Step Pregnancy Test Kit (Colloidal Gold immunochromatographic Assay)</tradeName>
    <deviceName>One Step Pregnancy Test Kit (Colloidal Gold immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Easy-Sweet Bio-medical Science and Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037568</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <riskClass>IVD Kendi Kendine Test</riskClass>
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    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <udiDi>06975228760088</udiDi>
    <basicUdiDi>B-06975228760088</basicUdiDi>
    <tradeName>One Step Pregnancy Test Kit (Colloidal Gold immunochromatographic Assay)</tradeName>
    <deviceName>One Step Pregnancy Test Kit (Colloidal Gold immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Easy-Sweet Bio-medical Science and Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037568</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESWT-M-FHC-03</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:23:19.058Z</lastUpdated>
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    <udiDi>06975228760071</udiDi>
    <basicUdiDi>B-06975228760071</basicUdiDi>
    <tradeName>One Step Pregnancy Test Kit (Colloidal Gold immunochromatographic Assay)</tradeName>
    <deviceName>One Step Pregnancy Test Kit (Colloidal Gold immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Easy-Sweet Bio-medical Science and Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037568</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESWT-M-FHC-02</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:23:18.046Z</lastUpdated>
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    <udiDi>06975090503349</udiDi>
    <basicUdiDi>B-06975090503349</basicUdiDi>
    <tradeName>06975090503349</tradeName>
    <deviceName>Anti-Müllerian Hormone (EECL)</deviceName>
    <manufacturerName>Accucise Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000045017</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>1030312000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:56:24.697Z</lastUpdated>
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    <udiDi>06975090503301</udiDi>
    <basicUdiDi>B-06975090503301</basicUdiDi>
    <tradeName>06975090503301</tradeName>
    <deviceName>Human Chorionic Gonadotropin (EECL)</deviceName>
    <manufacturerName>Accucise Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000045017</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1030112000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:56:19.877Z</lastUpdated>
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    <tradeName>06975090502342</tradeName>
    <deviceName>Anti-Müllerian Hormone (EECL)</deviceName>
    <manufacturerName>Accucise Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000045017</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1030311000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:54:24.202Z</lastUpdated>
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    <basicUdiDi>B-06975090502304</basicUdiDi>
    <tradeName>06975090502304</tradeName>
    <deviceName>Human Chorionic Gonadotropin (EECL)</deviceName>
    <manufacturerName>Accucise Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000045017</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:54:21.803Z</lastUpdated>
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    <basicUdiDi>B-06975090501307</basicUdiDi>
    <tradeName>06975090501307</tradeName>
    <deviceName>Human Chorionic Gonadotropin (EECL)</deviceName>
    <manufacturerName>Accucise Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000045017</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:53:58.583Z</lastUpdated>
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    <deviceName>Anti-Müllerian Hormone (EECL)</deviceName>
    <manufacturerName>Accucise Diagnostics Inc.</manufacturerName>
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    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1030301000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:53:18.502Z</lastUpdated>
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    <tradeName>06975090500300</tradeName>
    <deviceName>Human Chorionic Gonadotropin (EECL)</deviceName>
    <manufacturerName>Accucise Diagnostics Inc.</manufacturerName>
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    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1030101000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:53:12.094Z</lastUpdated>
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    <tradeName>Sharay Inhibin B (CLIA)</tradeName>
    <deviceName>Sharay Inhibin B (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <emdnDescription>INHIBIN A/B (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000840</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:49:49.473Z</lastUpdated>
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    <basicUdiDi>B-06975070766191</basicUdiDi>
    <tradeName>Sharay Inhibin B (CLIA)</tradeName>
    <deviceName>Sharay Inhibin B (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000410</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:43:11.942Z</lastUpdated>
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    <basicUdiDi>B-06975070762988</basicUdiDi>
    <tradeName>Sharay free-β-HCG (CLIA)</tradeName>
    <deviceName>Sharay free-β-HCG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18717001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:40:06.045Z</lastUpdated>
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    <tradeName>Sharay PAPP-A (CLIA)</tradeName>
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    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050210</emdnCode>
    <emdnDescription>PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18716001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:40:05.251Z</lastUpdated>
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