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    <udiDi>04260157632158</udiDi>
    <basicUdiDi>426015763845BsFlt-1K0XX36</basicUdiDi>
    <tradeName>B·R·A·H·M·S sFlt-1 KRYPTOR</tradeName>
    <deviceName>B·R·A·H·M·S sFlt-1 KRYPTOR</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050212</emdnCode>
    <emdnDescription>SOLUBLE FMS-LIKE TYROSINE KINASE-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>845075N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:34:20.090Z</lastUpdated>
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    <udiDi>00630414015583</udiDi>
    <basicUdiDi>0405686902122UY</basicUdiDi>
    <tradeName>ADVIA Centaur Soluble fms-like Tyrosine Kinase-1 (sFlt-1)</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_REAG_Soluble fms-like Tyrosine Kinase-1</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>
    <emdnCode>W0102050212</emdnCode>
    <emdnDescription>SOLUBLE FMS-LIKE TYROSINE KINASE-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10997829</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:32:28.539Z</lastUpdated>
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    <udiDi>D-MFG030063QW</udiDi>
    <basicUdiDi>B-MFG030063QW</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>A LC-MS/MS Kit for the quantitative measurement of tyrosine kinase inhibitor in plasma</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050212</emdnCode>
    <emdnDescription>SOLUBLE FMS-LIKE TYROSINE KINASE-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG030063</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:06:53.904Z</lastUpdated>
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    <udiDi>06974671102025</udiDi>
    <basicUdiDi>B-06974671102025</basicUdiDi>
    <tradeName>06974671102025</tradeName>
    <deviceName>Soluble Fms-like Tyrosine Kinase-1 Diagnostic Kit  (CLIA)</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050212</emdnCode>
    <emdnDescription>SOLUBLE FMS-LIKE TYROSINE KINASE-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-CLIA-CK-A029</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:10:35.583Z</lastUpdated>
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  <row>
    <udiDi>06974524062216</udiDi>
    <basicUdiDi>B-06974524062216</basicUdiDi>
    <tradeName>Soluble Fms-Iike Tyrosine Kinase-1 (sFlt-1) Test Kit (Homogeneous Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Soluble Fms-Iike Tyrosine Kinase-1 (sFlt-1) Test Kit (Homogeneous Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Nanjing Poclight Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039609</manufacturerSrn>
    <authorisedRepresentativeName>HUMISS TRADING S. L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000040177</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050212</emdnCode>
    <emdnDescription>SOLUBLE FMS-LIKE TYROSINE KINASE-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCLIA15135</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:00.528Z</lastUpdated>
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    <udiDi>06973642381476</udiDi>
    <basicUdiDi>B-06973642381476</basicUdiDi>
    <tradeName>06973642381476</tradeName>
    <deviceName>Tigsun sFIt-1 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>W0102050212</emdnCode>
    <emdnDescription>SOLUBLE FMS-LIKE TYROSINE KINASE-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:24:13.497Z</lastUpdated>
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    <udiDi>06973642381469</udiDi>
    <basicUdiDi>B-06973642381469</basicUdiDi>
    <tradeName>06973642381469</tradeName>
    <deviceName>Tigsun sFIt-1 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>W0102050212</emdnCode>
    <emdnDescription>SOLUBLE FMS-LIKE TYROSINE KINASE-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:24:11.897Z</lastUpdated>
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    <udiDi>06973642381452</udiDi>
    <basicUdiDi>B-06973642381452</basicUdiDi>
    <tradeName>06973642381452</tradeName>
    <deviceName>Tigsun sFIt-1 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>W0102050212</emdnCode>
    <emdnDescription>SOLUBLE FMS-LIKE TYROSINE KINASE-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:24:09.493Z</lastUpdated>
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    <udiDi>06973642381445</udiDi>
    <basicUdiDi>B-06973642381445</basicUdiDi>
    <tradeName>06973642381445</tradeName>
    <deviceName>Tigsun sFIt-1 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>W0102050212</emdnCode>
    <emdnDescription>SOLUBLE FMS-LIKE TYROSINE KINASE-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:24:07.896Z</lastUpdated>
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    <udiDi>06973642381438</udiDi>
    <basicUdiDi>B-06973642381438</basicUdiDi>
    <tradeName>06973642381438</tradeName>
    <deviceName>Tigsun sFIt-1 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>W0102050212</emdnCode>
    <emdnDescription>SOLUBLE FMS-LIKE TYROSINE KINASE-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:24:07.093Z</lastUpdated>
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    <udiDi>06973642381421</udiDi>
    <basicUdiDi>B-06973642381421</basicUdiDi>
    <tradeName>06973642381421</tradeName>
    <deviceName>Tigsun sFIt-1 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>W0102050212</emdnCode>
    <emdnDescription>SOLUBLE FMS-LIKE TYROSINE KINASE-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:24:05.490Z</lastUpdated>
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    <udiDi>06973642381414</udiDi>
    <basicUdiDi>B-06973642381414</basicUdiDi>
    <tradeName>06973642381414</tradeName>
    <deviceName>Tigsun sFIt-1 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>W0102050212</emdnCode>
    <emdnDescription>SOLUBLE FMS-LIKE TYROSINE KINASE-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:24:03.093Z</lastUpdated>
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  <row>
    <udiDi>06973642381407</udiDi>
    <basicUdiDi>B-06973642381407</basicUdiDi>
    <tradeName>06973642381407</tradeName>
    <deviceName>Tigsun sFIt-1 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>W0102050212</emdnCode>
    <emdnDescription>SOLUBLE FMS-LIKE TYROSINE KINASE-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:24:01.498Z</lastUpdated>
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    <udiDi>06973642381391</udiDi>
    <basicUdiDi>B-06973642381391</basicUdiDi>
    <tradeName>06973642381391</tradeName>
    <deviceName>Tigsun sFIt-1 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>W0102050212</emdnCode>
    <emdnDescription>SOLUBLE FMS-LIKE TYROSINE KINASE-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:24:00.693Z</lastUpdated>
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    <udiDi>06972719605552</udiDi>
    <basicUdiDi>B-06972719605552</basicUdiDi>
    <tradeName>06972719605552</tradeName>
    <deviceName>Soluble Fms‑like Tyrosine Kinase‑1 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050212</emdnCode>
    <emdnDescription>SOLUBLE FMS-LIKE TYROSINE KINASE-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:50:16.070Z</lastUpdated>
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    <udiDi>06972719605545</udiDi>
    <basicUdiDi>B-06972719605545</basicUdiDi>
    <tradeName>06972719605545</tradeName>
    <deviceName>Soluble Fms‑like Tyrosine Kinase‑1 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050212</emdnCode>
    <emdnDescription>SOLUBLE FMS-LIKE TYROSINE KINASE-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:50:15.269Z</lastUpdated>
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    <udiDi>06972719602735</udiDi>
    <basicUdiDi>B-06972719602735</basicUdiDi>
    <tradeName>06972719602735</tradeName>
    <deviceName>Soluble Fms‑like Tyrosine Kinase‑1 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050212</emdnCode>
    <emdnDescription>SOLUBLE FMS-LIKE TYROSINE KINASE-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:40:33.728Z</lastUpdated>
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    <udiDi>06972719602728</udiDi>
    <basicUdiDi>B-06972719602728</basicUdiDi>
    <tradeName>06972719602728</tradeName>
    <deviceName>Soluble Fms‑like Tyrosine Kinase‑1 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050212</emdnCode>
    <emdnDescription>SOLUBLE FMS-LIKE TYROSINE KINASE-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:40:33.155Z</lastUpdated>
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    <udiDi>06972719601905</udiDi>
    <basicUdiDi>B-06972719601905</basicUdiDi>
    <tradeName>06972719601905</tradeName>
    <deviceName>Soluble Fms‑like Tyrosine Kinase‑1 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050212</emdnCode>
    <emdnDescription>SOLUBLE FMS-LIKE TYROSINE KINASE-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:37:54.247Z</lastUpdated>
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    <udiDi>06972719601899</udiDi>
    <basicUdiDi>B-06972719601899</basicUdiDi>
    <tradeName>06972719601899</tradeName>
    <deviceName>Soluble Fms‑like Tyrosine Kinase‑1 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050212</emdnCode>
    <emdnDescription>SOLUBLE FMS-LIKE TYROSINE KINASE-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:37:52.657Z</lastUpdated>
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