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<eudamedExport entity="devices">
  <row>
    <udiDi>06933260204953</udiDi>
    <basicUdiDi>B-06933260204953</basicUdiDi>
    <tradeName>FT3 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>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0501802</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:52:58.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260204946</udiDi>
    <basicUdiDi>B-06933260204946</basicUdiDi>
    <tradeName>FT3 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>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0501801</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:52:57.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260204885</udiDi>
    <basicUdiDi>B-06933260204885</basicUdiDi>
    <tradeName>HBP 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>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0501605</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:52:47.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260204878</udiDi>
    <basicUdiDi>B-06933260204878</basicUdiDi>
    <tradeName>HBP 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>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0501604</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:52:45.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260204861</udiDi>
    <basicUdiDi>B-06933260204861</basicUdiDi>
    <tradeName>HBP 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>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0501603</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:52:44.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260204854</udiDi>
    <basicUdiDi>B-06933260204854</basicUdiDi>
    <tradeName>HBP 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>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0501602</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:52:42.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260204847</udiDi>
    <basicUdiDi>B-06933260204847</basicUdiDi>
    <tradeName>HBP 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>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0501601</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:52:42.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260204830</udiDi>
    <basicUdiDi>B-06933260204830</basicUdiDi>
    <tradeName>IL-6 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>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0501505</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:52:39.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260204823</udiDi>
    <basicUdiDi>B-06933260204823</basicUdiDi>
    <tradeName>IL-6 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>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0501504</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:52:38.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260204816</udiDi>
    <basicUdiDi>B-06933260204816</basicUdiDi>
    <tradeName>IL-6 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>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0501503</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:52:36.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260204809</udiDi>
    <basicUdiDi>B-06933260204809</basicUdiDi>
    <tradeName>IL-6 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>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0501502</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:52:35.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260204793</udiDi>
    <basicUdiDi>B-06933260204793</basicUdiDi>
    <tradeName>IL-6 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>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0501501</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:52:33.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260204786</udiDi>
    <basicUdiDi>B-06933260204786</basicUdiDi>
    <tradeName>PCT 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>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0501405</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:52:32.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260204779</udiDi>
    <basicUdiDi>B-06933260204779</basicUdiDi>
    <tradeName>PCT 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>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0501404</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:52:30.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260204762</udiDi>
    <basicUdiDi>B-06933260204762</basicUdiDi>
    <tradeName>PCT 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>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0501403</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:52:28.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260204755</udiDi>
    <basicUdiDi>B-06933260204755</basicUdiDi>
    <tradeName>PCT 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>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0501402</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:52:27.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260204748</udiDi>
    <basicUdiDi>B-06933260204748</basicUdiDi>
    <tradeName>PCT 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>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0501401</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:52:24.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260204731</udiDi>
    <basicUdiDi>B-06933260204731</basicUdiDi>
    <tradeName>SAA 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>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0501305</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:52:23.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260204724</udiDi>
    <basicUdiDi>B-06933260204724</basicUdiDi>
    <tradeName>SAA 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>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0501304</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:52:22.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260204717</udiDi>
    <basicUdiDi>B-06933260204717</basicUdiDi>
    <tradeName>SAA 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>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0501303</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:52:21.236Z</lastUpdated>
  </row>
</eudamedExport>