<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-VID156F8</udiDi>
    <basicUdiDi>B-VID156F8</basicUdiDi>
    <tradeName>Light Peptide Neurofilament Protein Test Kit (FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060599</emdnCode>
    <emdnDescription>NEOENDOCRINE FUNCTION ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID156-07-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:21:01.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIS100-402aHG6H</udiDi>
    <basicUdiDi>B-FIS100-402aHG6H</basicUdiDi>
    <tradeName>S100-β Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060599</emdnCode>
    <emdnDescription>NEOENDOCRINE FUNCTION ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIS100-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:33:29.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIS100-402a99</udiDi>
    <basicUdiDi>B-FIS100-402a99</basicUdiDi>
    <tradeName>S100-β Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>S100-β Quantitative Test Kit (Time-Resolved FIA)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060599</emdnCode>
    <emdnDescription>NEOENDOCRINE FUNCTION ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIS100-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:33:28.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>08034063842880</udiDi>
    <basicUdiDi>B-08034063842880</basicUdiDi>
    <tradeName>17-KETOSTEROIDS</tradeName>
    <deviceName>17-KETOSTEROIDS</deviceName>
    <manufacturerName>FAR Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000041136</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060505</emdnCode>
    <emdnDescription>17-KETOSTEROIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR04-20</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:02:22.728Z</lastUpdated>
  </row>
</eudamedExport>