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    <udiDi>06972665701032</udiDi>
    <basicUdiDi>B-06972665701032</basicUdiDi>
    <tradeName>B-raf Gene Mutation Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V.  Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands. Email：peter@lotusnl.com</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:33:48.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972665701049</udiDi>
    <basicUdiDi>B-06972665701049</basicUdiDi>
    <tradeName>MGMT Gene Methylation Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V.  Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands. Email：peter@lotusnl.com</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:33:48.425Z</lastUpdated>
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  <row>
    <udiDi>06972665701056</udiDi>
    <basicUdiDi>B-06972665701056</basicUdiDi>
    <tradeName>Thyroid carcinoma RET Gene Fusions Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V.  Address：Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands. Email：peter@lotusnl.com</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:33:48.416Z</lastUpdated>
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    <udiDi>06972665701063</udiDi>
    <basicUdiDi>B-06972665701063</basicUdiDi>
    <tradeName>EGFR Gene Mutations Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V.  Address：Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands. Email：peter@lotusnl.com</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:33:48.407Z</lastUpdated>
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  <row>
    <udiDi>06972665701070</udiDi>
    <basicUdiDi>B-06972665701070</basicUdiDi>
    <tradeName>Human NTRK Genes Fusion Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:peter@lotusnl.com</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:33:48.400Z</lastUpdated>
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  <row>
    <udiDi>06972665701087</udiDi>
    <basicUdiDi>B-06972665701087</basicUdiDi>
    <tradeName>Human BCR-ABL Gene T315I Mutation Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:peter@lotusnl.com</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:33:48.392Z</lastUpdated>
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  <row>
    <udiDi>06972665701094</udiDi>
    <basicUdiDi>B-06972665701094</basicUdiDi>
    <tradeName>Human PAX1 Gene Methylation Detection Kit （Multiplex Fluorescence Polymerase Chain Reaction）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:peter@lotusnl.com</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:33:48.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972665701100</udiDi>
    <basicUdiDi>B-06972665701100</basicUdiDi>
    <tradeName>2019 Novel Coronavirus RNA Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:peter@lotusnl.com</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:33:48.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972665701117</udiDi>
    <basicUdiDi>B-06972665701117</basicUdiDi>
    <tradeName>MLH1 Gene Methlyation Detection Kit  Multiplex Fluorescence Polymerase Chain Reaction</tradeName>
    <deviceName></deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:peter@lotusnl.com</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:33:48.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972665701124</udiDi>
    <basicUdiDi>B-06972665701124</basicUdiDi>
    <tradeName>ALK/ROS1/RET Gene Fusion Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V.  Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands. Email：peter@lotusnl.com</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:33:48.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972665701131</udiDi>
    <basicUdiDi>B-06972665701131</basicUdiDi>
    <tradeName>Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V.  Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:peter@lotusnl.com</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:33:48.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972665701148</udiDi>
    <basicUdiDi>B-06972665701148</basicUdiDi>
    <tradeName>Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V.  Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:peter@lotusnl.com</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:33:48.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972665701155</udiDi>
    <basicUdiDi>B-06972665701155</basicUdiDi>
    <tradeName>K-ras Gene Mutations Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V. Address:Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:peter@lotusnl.com</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:33:48.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972665702015</udiDi>
    <basicUdiDi>B-06972665702015</basicUdiDi>
    <tradeName>EGFR Gene T790M Mutation Detection Kit (Digital PCR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V.  Address：Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands. Email：peter@lotusnl.com</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:33:48.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972665702022</udiDi>
    <basicUdiDi>B-06972665702022</basicUdiDi>
    <tradeName>EGFR Gene T790M Mutation Detection Kit (Digital PCR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V.  Address：Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands. Email：peter@lotusnl.com</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:33:48.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972665703012</udiDi>
    <basicUdiDi>B-06972665703012</basicUdiDi>
    <tradeName>2019  Novel  Coronavirus Antigen Rapid Test(Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:peter@lotusnl.com</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:33:48.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972665704019</udiDi>
    <basicUdiDi>B-06972665704019</basicUdiDi>
    <tradeName>Human Lung Tissue Mycobacteria Identification Detection Kit (Nucleic Acid Mass Spectrometry)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:peter@lotusnl.com</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:33:48.296Z</lastUpdated>
  </row>
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