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<eudamedExport entity="devices">
  <row>
    <udiDi>06933260206049</udiDi>
    <basicUdiDi>B-06933260206049</basicUdiDi>
    <tradeName>INS Rapid Quantitative Test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160999</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0504001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:55:05.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260205936</udiDi>
    <basicUdiDi>B-06933260205936</basicUdiDi>
    <tradeName>AMH Rapid Quantitative Test(Chemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160999</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0503705</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:54:51.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260205929</udiDi>
    <basicUdiDi>B-06933260205929</basicUdiDi>
    <tradeName>AMH Rapid Quantitative Test(Chemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160999</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0503704</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:54:48.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260205912</udiDi>
    <basicUdiDi>B-06933260205912</basicUdiDi>
    <tradeName>AMH Rapid Quantitative Test(Chemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160999</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0503703</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:54:46.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260205905</udiDi>
    <basicUdiDi>B-06933260205905</basicUdiDi>
    <tradeName>AMH Rapid Quantitative Test(Chemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160999</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0503702</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:54:45.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260205899</udiDi>
    <basicUdiDi>B-06933260205899</basicUdiDi>
    <tradeName>AMH Rapid Quantitative Test(Chemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160999</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0503701</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:54:44.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260204939</udiDi>
    <basicUdiDi>B-06933260204939</basicUdiDi>
    <tradeName>TSH Rapid Quantitative Test(Chemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160903</emdnCode>
    <emdnDescription>THYROID-STIMULATING HORMONE - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0501705</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:52:54.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260204922</udiDi>
    <basicUdiDi>B-06933260204922</basicUdiDi>
    <tradeName>TSH Rapid Quantitative Test(Chemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160903</emdnCode>
    <emdnDescription>THYROID-STIMULATING HORMONE - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0501704</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:52:53.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260204915</udiDi>
    <basicUdiDi>B-06933260204915</basicUdiDi>
    <tradeName>TSH Rapid Quantitative Test(Chemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160903</emdnCode>
    <emdnDescription>THYROID-STIMULATING HORMONE - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0501703</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:52:52.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260204908</udiDi>
    <basicUdiDi>B-06933260204908</basicUdiDi>
    <tradeName>TSH Rapid Quantitative Test(Chemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160903</emdnCode>
    <emdnDescription>THYROID-STIMULATING HORMONE - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0501702</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:52:51.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260204892</udiDi>
    <basicUdiDi>B-06933260204892</basicUdiDi>
    <tradeName>TSH Rapid Quantitative Test(Chemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160903</emdnCode>
    <emdnDescription>THYROID-STIMULATING HORMONE - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0501701</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:52:48.851Z</lastUpdated>
  </row>
</eudamedExport>