<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06933260206490</udiDi>
    <basicUdiDi>B-06933260206490</basicUdiDi>
    <tradeName>HbA1c Assay Kit (HPLC)</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>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT07001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:53.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260206483</udiDi>
    <basicUdiDi>B-06933260206483</basicUdiDi>
    <tradeName>Total cholesterol test strip（Electrochemical Method）</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>W0101060102</emdnCode>
    <emdnDescription>CHOLESTEROL TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT06011</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:50.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260206476</udiDi>
    <basicUdiDi>B-06933260206476</basicUdiDi>
    <tradeName>Blood Glucose Test strip(glucose dehydrogenase method)</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>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT06002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:48.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260206469</udiDi>
    <basicUdiDi>B-06933260206469</basicUdiDi>
    <tradeName>Blood Ketone Test Strip（Electrochemical Method）</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>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT06009</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:47.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260206452</udiDi>
    <basicUdiDi>B-06933260206452</basicUdiDi>
    <tradeName>Uric Acid Test Strip （Electrochemical Method）</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>W0101060106</emdnCode>
    <emdnDescription>UREA TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT06007</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:45.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260206445</udiDi>
    <basicUdiDi>B-06933260206445</basicUdiDi>
    <tradeName>SARS-CoV-2 Nucleic Acid eRDA Rapid Qualitative Test Kit（Colloidal gold）</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>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0300504</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:44.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260206438</udiDi>
    <basicUdiDi>B-06933260206438</basicUdiDi>
    <tradeName>SARS-CoV-2 Nucleic Acid eRDA Rapid Qualitative Test Kit（Colloidal gold）</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>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0300503</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:42.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260206421</udiDi>
    <basicUdiDi>B-06933260206421</basicUdiDi>
    <tradeName>SARS-CoV-2 Nucleic Acid eRDA Rapid Qualitative Test Kit（Colloidal gold）</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>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0300502</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:41.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260206414</udiDi>
    <basicUdiDi>B-06933260206414</basicUdiDi>
    <tradeName>SARS-CoV-2 Nucleic Acid eRDA Rapid Qualitative Test Kit（Colloidal gold）</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>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0300501</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:39.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260206384</udiDi>
    <basicUdiDi>B-06933260206384</basicUdiDi>
    <tradeName>Urinalysis Reagent Strips</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>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0802004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:38.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260206377</udiDi>
    <basicUdiDi>B-06933260206377</basicUdiDi>
    <tradeName>Urinalysis Reagent Strips</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>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0802003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:37.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260206360</udiDi>
    <basicUdiDi>B-06933260206360</basicUdiDi>
    <tradeName>Urinalysis Reagent Strips</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>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0802002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:35.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260206353</udiDi>
    <basicUdiDi>B-06933260206353</basicUdiDi>
    <tradeName>Urinalysis Reagent Strips</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>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0802001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:35.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260206346</udiDi>
    <basicUdiDi>B-06933260206346</basicUdiDi>
    <tradeName>Malaria P.f/Pan Antigen Rapid Test</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>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0102201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:32.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260206339</udiDi>
    <basicUdiDi>B-06933260206339</basicUdiDi>
    <tradeName>Malaria P.f/P.v Antigen Rapid Test</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>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0102101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:31.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260206322</udiDi>
    <basicUdiDi>B-06933260206322</basicUdiDi>
    <tradeName>Malaria P.v Antigen Rapid Test</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>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0102001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:29.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260206315</udiDi>
    <basicUdiDi>B-06933260206315</basicUdiDi>
    <tradeName>Malaria P.f Antigen Rapid Test</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>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0101901</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:27.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260206308</udiDi>
    <basicUdiDi>B-06933260206308</basicUdiDi>
    <tradeName>Dengue Ag &amp;Ab Combo Rapid Test</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>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0101801</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:26.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260206292</udiDi>
    <basicUdiDi>B-06933260206292</basicUdiDi>
    <tradeName>Dengue IgG/IgM Rapid Test</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>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0101701</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:25.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260206285</udiDi>
    <basicUdiDi>B-06933260206285</basicUdiDi>
    <tradeName>NSE 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>BT0504405</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:24.266Z</lastUpdated>
  </row>
</eudamedExport>