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<eudamedExport entity="devices">
  <row>
    <udiDi>06970341681203</udiDi>
    <basicUdiDi>B-06970341681203</basicUdiDi>
    <tradeName>Estradiol (Electrochemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ESTRADIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>697034</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:40.009Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341681210</udiDi>
    <basicUdiDi>B-06970341681210</basicUdiDi>
    <tradeName>Insulin (Electrochemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>695027</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:39.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341681234</udiDi>
    <basicUdiDi>B-06970341681234</basicUdiDi>
    <tradeName>Lipoprotein-Associated Phospholipase A2 (Electrochemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>691054</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:39.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341681647</udiDi>
    <basicUdiDi>B-06970341681647</basicUdiDi>
    <tradeName>D-dimer Assay Kit (Lateral Flow Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320303502</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:39.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341684983</udiDi>
    <basicUdiDi>B-06970341684983</basicUdiDi>
    <tradeName>HbA1c Control Material</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320200302</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:39.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685553</udiDi>
    <basicUdiDi>B-06970341685553</basicUdiDi>
    <tradeName>Anti-Mullerian Hormone(eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>697043</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:39.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685560</udiDi>
    <basicUdiDi>B-06970341685560</basicUdiDi>
    <tradeName>Anti-Mullerian Hormone(eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>697044</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:39.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685577</udiDi>
    <basicUdiDi>B-06970341685577</basicUdiDi>
    <tradeName>Anti-Mullerian Hormone(eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>697045</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:39.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685584</udiDi>
    <basicUdiDi>B-06970341685584</basicUdiDi>
    <tradeName>Anti-Mullerian Hormone(eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>697046</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:39.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685713</udiDi>
    <basicUdiDi>69703416803205048JP</basicUdiDi>
    <tradeName>Alpha-Fetoprotein (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320501401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:39.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685720</udiDi>
    <basicUdiDi>69703416803205048JP</basicUdiDi>
    <tradeName>Alpha-Fetoprotein (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320501403</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:39.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685744</udiDi>
    <basicUdiDi>B-06970341685744</basicUdiDi>
    <tradeName>Thyroglobulin Antibody (Electrochemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>690043</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:39.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685775</udiDi>
    <basicUdiDi>B-06970341685775</basicUdiDi>
    <tradeName>Thyroid Peroxidase Antibody ( Electrochemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>690039</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:39.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685782</udiDi>
    <basicUdiDi>69703416803205027JF</basicUdiDi>
    <tradeName>Cancer Antigen 15-3 (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320500701</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:39.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685799</udiDi>
    <basicUdiDi>69703416803205027JF</basicUdiDi>
    <tradeName>Cancer Antigen 15-3 (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320500703</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:39.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685805</udiDi>
    <basicUdiDi>69703416803205024J9</basicUdiDi>
    <tradeName>Carbonhydrate Antigen 19-9 (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970341685805</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:39.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685812</udiDi>
    <basicUdiDi>69703416803205024J9</basicUdiDi>
    <tradeName>Carbonhydrate Antigen 19-9 (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320500803</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:39.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685829</udiDi>
    <basicUdiDi>69703416803205049JR</basicUdiDi>
    <tradeName>Cancer Antigen 125 (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320500901</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:39.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685836</udiDi>
    <basicUdiDi>69703416803205049JR</basicUdiDi>
    <tradeName>Cancer Antigen 125 (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320500903</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:39.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685843</udiDi>
    <basicUdiDi>69703416803205062JH</basicUdiDi>
    <tradeName>Carcinoembryonic Antigen (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320500501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:39.281Z</lastUpdated>
  </row>
</eudamedExport>