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<eudamedExport entity="devices">
  <row>
    <udiDi>06925912720614</udiDi>
    <basicUdiDi>692591270255HL</basicUdiDi>
    <tradeName>iFlash-EB EA IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010504040108</emdnCode>
    <emdnDescription>EBV EA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86141G-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:02:07.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912720607</udiDi>
    <basicUdiDi>692591270256HN</basicUdiDi>
    <tradeName>iFlash-IGF-1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060403</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR I (SOMATOMEDIN C)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86135-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:02:06.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912720591</udiDi>
    <basicUdiDi>692591270255HL</basicUdiDi>
    <tradeName>iFlash-EB EA IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010504040108</emdnCode>
    <emdnDescription>EBV EA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86141G-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:02:05.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912720553</udiDi>
    <basicUdiDi>692591270282HP</basicUdiDi>
    <tradeName>06925912720553</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BC0212</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:02:04.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912720546</udiDi>
    <basicUdiDi>692591270271HJ</basicUdiDi>
    <tradeName>iFlash-IGFBP-3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060406</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86127-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:02:03.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912720508</udiDi>
    <basicUdiDi>692591270275HS</basicUdiDi>
    <tradeName>iFlash-Calcitonin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060301</emdnCode>
    <emdnDescription>CALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86291-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:02:00.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912720478</udiDi>
    <basicUdiDi>692591270277HW</basicUdiDi>
    <tradeName>iFlash-Osteocalcin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86289-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:01:58.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912720287</udiDi>
    <basicUdiDi>692591270266HR</basicUdiDi>
    <tradeName>iFlash-hs-cTnI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86305</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:01:37.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912719991</udiDi>
    <basicUdiDi>692591270282HP</basicUdiDi>
    <tradeName>06925912719991</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BC0149</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:01:29.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912719953</udiDi>
    <basicUdiDi>692591270151H7</basicUdiDi>
    <tradeName>iFlash-IL-6</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01030609</emdnCode>
    <emdnDescription>INTERLEUKIN 6 (IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86312</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:01:27.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912719946</udiDi>
    <basicUdiDi>692591270265HP</basicUdiDi>
    <tradeName>iFlash-CRP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86313</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:01:25.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912719748</udiDi>
    <basicUdiDi>692591270270HG</basicUdiDi>
    <tradeName>iFlash-Total IgE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86285E-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:01:21.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912719427</udiDi>
    <basicUdiDi>692591270157HK</basicUdiDi>
    <tradeName>iFlash-Gastrin-17</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102069001</emdnCode>
    <emdnDescription>GASTRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86055-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:01:12.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912719274</udiDi>
    <basicUdiDi>692591270103GU</basicUdiDi>
    <tradeName>iFlash-CMV IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040203</emdnCode>
    <emdnDescription>CMV IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88032G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:00:54.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912719267</udiDi>
    <basicUdiDi>692591270098HU</basicUdiDi>
    <tradeName>iFlash-Free PSA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102030114</emdnCode>
    <emdnDescription>FREE PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:00:53.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912719250</udiDi>
    <basicUdiDi>692591270097HS</basicUdiDi>
    <tradeName>iFlash-Total PSA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:00:52.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912719229</udiDi>
    <basicUdiDi>692591270100GN</basicUdiDi>
    <tradeName>iFlash-Chlamydia pn. IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010116</emdnCode>
    <emdnDescription>CHLAMYDIA PNEUMONIAE ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88014M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:00:47.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912719212</udiDi>
    <basicUdiDi>692591270099HW</basicUdiDi>
    <tradeName>iFlash-Chlamydia pn. IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010115</emdnCode>
    <emdnDescription>CHLAMYDIA PNEUMONAIE ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88013G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:00:46.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912719205</udiDi>
    <basicUdiDi>692591270094HL</basicUdiDi>
    <tradeName>iFlash-Mycoplasma pn. IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88004M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:00:45.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912719199</udiDi>
    <basicUdiDi>692591270093HJ</basicUdiDi>
    <tradeName>iFlash-Mycoplasma pn. IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88003G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:00:43.817Z</lastUpdated>
  </row>
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