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<eudamedExport entity="devices">
  <row>
    <udiDi>06974674893302</udiDi>
    <basicUdiDi>B-06974674893302</basicUdiDi>
    <tradeName>Glutamic Acid Decarboxylase Antibody (GAD65) Detection Kit(CLIA)</tradeName>
    <deviceName>Glutamic Acid Decarboxylase Antibody (GAD65) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060199</emdnCode>
    <emdnDescription>DIABETES ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0202</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:19:00.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674893296</udiDi>
    <basicUdiDi>B-06974674893296</basicUdiDi>
    <tradeName>Fibrin/Fibrinogen Degradation Products(FDP) Detection Kit(CLIA)</tradeName>
    <deviceName>Fibrin/Fibrinogen Degradation Products(FDP) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:58.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674893289</udiDi>
    <basicUdiDi>B-06974674893289</basicUdiDi>
    <tradeName>Tissue plasminogen activator-Plasminogen activator inhibitor Complex(t-PAIC) Detection Kit(CLIA)</tradeName>
    <deviceName>Tissue plasminogen activator-Plasminogen activator inhibitor Complex(t-PAIC) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020506</emdnCode>
    <emdnDescription>PLASMINOGEN ACTIVATOR-INHIBITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0200</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:56.040Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674893265</udiDi>
    <basicUdiDi>B-06974674893265</basicUdiDi>
    <tradeName>α2-plasmininhibitor-Plasmin Complex(PIC) Detection Kit(CLIA)</tradeName>
    <deviceName>α2-plasmininhibitor-Plasmin Complex(PIC) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020504</emdnCode>
    <emdnDescription>PLASMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0198</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:54.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674893272</udiDi>
    <basicUdiDi>B-06974674893272</basicUdiDi>
    <tradeName>Thrombomodulin(TM) Detection Kit(CLIA)</tradeName>
    <deviceName>Thrombomodulin(TM) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020699</emdnCode>
    <emdnDescription>COAGULATION INHIBITORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0199</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:53.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674893234</udiDi>
    <basicUdiDi>B-06974674893234</basicUdiDi>
    <tradeName>Insulin-like Growth Factor 1 (IGF-1) Detection Kit(CLIA)</tradeName>
    <deviceName>Insulin-like Growth Factor 1 (IGF-1) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060403</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR I (SOMATOMEDIN C)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0195</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:52.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674893258</udiDi>
    <basicUdiDi>B-06974674893258</basicUdiDi>
    <tradeName>Thrombin-Antithrombin Complex(TAT) Detection Kit(CLIA)</tradeName>
    <deviceName>Thrombin-Antithrombin Complex(TAT) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0197</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:48.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674893241</udiDi>
    <basicUdiDi>B-06974674893241</basicUdiDi>
    <tradeName>Growth Hormone  (GH) Detection Kit(CLIA)</tradeName>
    <deviceName>Growth Hormone  (GH) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0196</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:48.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674893227</udiDi>
    <basicUdiDi>B-06974674893227</basicUdiDi>
    <tradeName>Mycoplasma Pheumonia IgM (MP IgM) Detection Kit(CLIA)</tradeName>
    <deviceName>Mycoplasma Pheumonia IgM (MP IgM) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040501</emdnCode>
    <emdnDescription>ADENOVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0194</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:31.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674893210</udiDi>
    <basicUdiDi>B-06974674893210</basicUdiDi>
    <tradeName>Mycoplasma Pheumonia IgG (MP IgG) Detection Kit(CLIA)</tradeName>
    <deviceName>Mycoplasma Pheumonia IgG (MP IgG) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080207</emdnCode>
    <emdnDescription>MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0193</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:31.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674893203</udiDi>
    <basicUdiDi>B-06974674893203</basicUdiDi>
    <tradeName>Adenovirus IgM Detection Kit(CLIA)</tradeName>
    <deviceName>Adenovirus IgM Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040501</emdnCode>
    <emdnDescription>ADENOVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0192</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:30.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674893197</udiDi>
    <basicUdiDi>B-06974674893197</basicUdiDi>
    <tradeName>Respiratory Syncytial Virus IgM (RSV-IgM) Detection Kit(CLIA)</tradeName>
    <deviceName>Respiratory Syncytial Virus IgM (RSV-IgM) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040505</emdnCode>
    <emdnDescription>RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0191</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:29.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674893180</udiDi>
    <basicUdiDi>B-06974674893180</basicUdiDi>
    <tradeName>Intact Parathyroid Hormone (Intact PTH) Detection Kit(CLIA)</tradeName>
    <deviceName>Intact Parathyroid Hormone (Intact PTH) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0190</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:25.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674893173</udiDi>
    <basicUdiDi>B-06974674893173</basicUdiDi>
    <tradeName>Calcitonin(CT)Detection Kit(CLIA)</tradeName>
    <deviceName>Calcitonin(CT)Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060301</emdnCode>
    <emdnDescription>CALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0189</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:24.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674893166</udiDi>
    <basicUdiDi>B-06974674893166</basicUdiDi>
    <tradeName>Ferritin (FERR) Detection Kit(CLIA)</tradeName>
    <deviceName>Ferritin (FERR) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0188</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:23.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674893159</udiDi>
    <basicUdiDi>B-06974674893159</basicUdiDi>
    <tradeName>Vitamin B12 Detection Kit(CLIA)</tradeName>
    <deviceName>Vitamin B12 Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070301</emdnCode>
    <emdnDescription>VITAMIN B 12 / FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0187</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:23.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674893142</udiDi>
    <basicUdiDi>B-06974674893142</basicUdiDi>
    <tradeName>Folic Acid (FA) Detection Kit(CLIA)</tradeName>
    <deviceName>Folic Acid (FA) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0186</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:19.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674893135</udiDi>
    <basicUdiDi>B-06974674893135</basicUdiDi>
    <tradeName>Hydroxy Vitamin D(25-OH-VD) Detection Kit(CLIA)</tradeName>
    <deviceName>Hydroxy Vitamin D(25-OH-VD) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0185</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:18.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674893128</udiDi>
    <basicUdiDi>B-06974674893128</basicUdiDi>
    <tradeName>Adrendcorticotrophic Hormone(ACTH)Detection Kit(CLIA)</tradeName>
    <deviceName>Adrendcorticotrophic Hormone(ACTH)Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060299</emdnCode>
    <emdnDescription>RENAL METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0184</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:17.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674893111</udiDi>
    <basicUdiDi>B-06974674893111</basicUdiDi>
    <tradeName>Cortisol Detection Kit(CLIA)</tradeName>
    <deviceName>Cortisol Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0183</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:16.759Z</lastUpdated>
  </row>
</eudamedExport>