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    <basicUdiDi>B-06974521001010</basicUdiDi>
    <tradeName>AMH Assay kit CLIA</tradeName>
    <deviceName>AMH Assay kit CLIA</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM080036</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:28:56.816Z</lastUpdated>
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    <udiDi>06974521000488</udiDi>
    <basicUdiDi>B-06974521000488</basicUdiDi>
    <tradeName>Diagnostic Kit for Anti-Müllerian Hormone (AMH) (Time-resolved Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Diagnostic Kit for Anti-Müllerian Hormone (AMH) (Time-resolved Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPF030025</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:27:07.033Z</lastUpdated>
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    <udiDi>06974464591586</udiDi>
    <basicUdiDi>B-06974464591586</basicUdiDi>
    <tradeName>AMH Rapid Test Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>AMH Rapid Test Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Guangzhou Decheng Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013536</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5364C4X025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:09:29.338Z</lastUpdated>
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    <udiDi>06974323014317</udiDi>
    <basicUdiDi>B-06974323014317</basicUdiDi>
    <tradeName>06974323014317</tradeName>
    <deviceName>AMH rapid test cassette (Rare earth nano fluorescence immunochromatography)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:58:00.722Z</lastUpdated>
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    <udiDi>06974323014300</udiDi>
    <basicUdiDi>B-06974323014300</basicUdiDi>
    <tradeName>06974323014300</tradeName>
    <deviceName>AMH rapid test cassette (Rare earth nano fluorescence immunochromatography)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:57:58.322Z</lastUpdated>
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    <udiDi>06974323014294</udiDi>
    <basicUdiDi>B-06974323014294</basicUdiDi>
    <tradeName>06974323014294</tradeName>
    <deviceName>AMH rapid test cassette (Rare earth nano fluorescence immunochromatography)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:57:57.436Z</lastUpdated>
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    <udiDi>06973861683702</udiDi>
    <basicUdiDi>B-06973861683702</basicUdiDi>
    <tradeName>06973861683702</tradeName>
    <deviceName>AMH Rapid Test Kit</deviceName>
    <manufacturerName>Anbio (Xiamen) Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023936</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02041002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:42:02.238Z</lastUpdated>
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    <udiDi>06973841000925</udiDi>
    <basicUdiDi>B-06973841000925</basicUdiDi>
    <tradeName>Anti-Mullerian Hormone Test Kit (Immunofluorescence)</tradeName>
    <deviceName>Anti-Mullerian 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>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA0190</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:39:01.657Z</lastUpdated>
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    <udiDi>06973642381650</udiDi>
    <basicUdiDi>B-06973642381650</basicUdiDi>
    <tradeName>06973642381650</tradeName>
    <deviceName>Tigsun AMH Antigen Rapid Test (FIA)</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:26:29.744Z</lastUpdated>
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    <udiDi>06973642381643</udiDi>
    <basicUdiDi>B-06973642381643</basicUdiDi>
    <tradeName>06973642381643</tradeName>
    <deviceName>Tigsun AMH Antigen Rapid Test (FIA)</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:26:28.023Z</lastUpdated>
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    <udiDi>06973642381636</udiDi>
    <basicUdiDi>B-06973642381636</basicUdiDi>
    <tradeName>06973642381636</tradeName>
    <deviceName>Tigsun AMH Antigen Rapid Test (FIA)</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:26:27.222Z</lastUpdated>
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    <udiDi>06973642381629</udiDi>
    <basicUdiDi>B-06973642381629</basicUdiDi>
    <tradeName>06973642381629</tradeName>
    <deviceName>Tigsun AMH Antigen Rapid Test (FIA)</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:26:26.441Z</lastUpdated>
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    <udiDi>06973642381612</udiDi>
    <basicUdiDi>B-06973642381612</basicUdiDi>
    <tradeName>06973642381612</tradeName>
    <deviceName>Tigsun AMH Antigen Rapid Test (FIA)</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:26:21.618Z</lastUpdated>
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    <udiDi>06973642381605</udiDi>
    <basicUdiDi>B-06973642381605</basicUdiDi>
    <tradeName>06973642381605</tradeName>
    <deviceName>Tigsun AMH Antigen Rapid Test (FIA)</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:26:20.812Z</lastUpdated>
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    <udiDi>06973642381599</udiDi>
    <basicUdiDi>B-06973642381599</basicUdiDi>
    <tradeName>06973642381599</tradeName>
    <deviceName>Tigsun AMH Antigen Rapid Test (FIA)</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:26:20.017Z</lastUpdated>
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    <udiDi>06973642381582</udiDi>
    <basicUdiDi>B-06973642381582</basicUdiDi>
    <tradeName>06973642381582</tradeName>
    <deviceName>Tigsun AMH Antigen Rapid Test (FIA)</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:26:19.225Z</lastUpdated>
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    <udiDi>06973642381575</udiDi>
    <basicUdiDi>B-06973642381575</basicUdiDi>
    <tradeName>06973642381575</tradeName>
    <deviceName>Tigsun AMH Antigen Rapid Test (FIA)</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:26:14.424Z</lastUpdated>
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    <udiDi>06971763220155</udiDi>
    <basicUdiDi>B-06971763220155</basicUdiDi>
    <tradeName>06971763220155</tradeName>
    <deviceName>AMH 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>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0015-03</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:47:01.540Z</lastUpdated>
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    <udiDi>06971354101825</udiDi>
    <basicUdiDi>B-06971354101825</basicUdiDi>
    <tradeName>ReLIA</tradeName>
    <deviceName>Anti-Mullerian Hormone Test (Colloidal Gold)</deviceName>
    <manufacturerName>ReLIA Biotechnologies (Jiangsu), Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000042042</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RG16388-50T</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:54:21.968Z</lastUpdated>
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    <udiDi>06971354101580</udiDi>
    <basicUdiDi>B-06971354101580</basicUdiDi>
    <tradeName>ReLIA</tradeName>
    <deviceName>Anti-Mullerian Hormone Test (Colloidal Gold)</deviceName>
    <manufacturerName>ReLIA Biotechnologies (Jiangsu), Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000042042</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RG16364-20T</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:53:34.797Z</lastUpdated>
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