<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06925912720300</udiDi>
    <basicUdiDi>692591270257HQ</basicUdiDi>
    <tradeName>iFlash-CenpB IgG</tradeName>
    <deviceName>iFlash-CenpB IgG</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>IVDR 2017/746</legislation>
    <emdnCode>W0102100115</emdnCode>
    <emdnDescription>ANTI-CENTROMERE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86078G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:35:59.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250289500548</udiDi>
    <basicUdiDi>B-04250289500548</basicUdiDi>
    <tradeName>AESKULISA® Cenp-B</tradeName>
    <deviceName>AESKULISA® Cenp-B</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100115</emdnCode>
    <emdnDescription>ANTI-CENTROMERE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3112</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T15:37:55.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060147194062</udiDi>
    <basicUdiDi>B-86060147194062</basicUdiDi>
    <tradeName>Centromere</tradeName>
    <deviceName>Centromere</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100115</emdnCode>
    <emdnDescription>ANTI-CENTROMERE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N715A24CNM</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:14:00.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912721185</udiDi>
    <basicUdiDi>692591270257HQ</basicUdiDi>
    <tradeName>iFlash-CenpB 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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100115</emdnCode>
    <emdnDescription>ANTI-CENTROMERE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86078G-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:11.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435287148657</udiDi>
    <basicUdiDi>B-08435287148657</basicUdiDi>
    <tradeName>08435287148657</tradeName>
    <deviceName>ANTI-CENTROMERE B ANTIBODIES (CENP-B)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100115</emdnCode>
    <emdnDescription>ANTI-CENTROMERE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>44865</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:51:05.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950595632</udiDi>
    <basicUdiDi>B-08426950595632</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® Centromere Reagents</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100115</emdnCode>
    <emdnDescription>ANTI-CENTROMERE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701198</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:20:32.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424225640</udiDi>
    <basicUdiDi>B-06975424225640</basicUdiDi>
    <tradeName>Anti-centromere Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Anti-centromere Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100115</emdnCode>
    <emdnDescription>ANTI-CENTROMERE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL234901C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:43:23.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223967</udiDi>
    <basicUdiDi>B-06975424223967</basicUdiDi>
    <tradeName>06975424223967</tradeName>
    <deviceName>Anti- centromere Kit  (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100115</emdnCode>
    <emdnDescription>ANTI-CENTROMERE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL234906</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:40:37.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424221901</udiDi>
    <basicUdiDi>B-06975424221901</basicUdiDi>
    <tradeName>Anti-centromere Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Anti-centromere Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100115</emdnCode>
    <emdnDescription>ANTI-CENTROMERE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20T</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:37:06.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975070769376</udiDi>
    <basicUdiDi>B-06975070769376</basicUdiDi>
    <tradeName>Sharay Anti-CENP-B IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-CENP-B IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100115</emdnCode>
    <emdnDescription>ANTI-CENTROMERE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000726</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:50:34.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975070760977</udiDi>
    <basicUdiDi>B-06975070760977</basicUdiDi>
    <tradeName>Sharay Anti-CENP-B IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-CENP-B IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100115</emdnCode>
    <emdnDescription>ANTI-CENTROMERE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18109001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:33:08.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640327462018</udiDi>
    <basicUdiDi>764032746CENPBMAGAZINEU44</basicUdiDi>
    <tradeName>07640327462018</tradeName>
    <deviceName>MosaiQ CENP-B Magazine</deviceName>
    <manufacturerName>AliveDx Suisse SA</manufacturerName>
    <manufacturerSrn>CH-MF-000024025</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100115</emdnCode>
    <emdnDescription>ANTI-CENTROMERE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:44:16.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>07333066014562</udiDi>
    <basicUdiDi>7333066BUDI0075MD</basicUdiDi>
    <tradeName>EliA CENP Well</tradeName>
    <deviceName>EliA CENP</deviceName>
    <manufacturerName>Phadia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000014170</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100115</emdnCode>
    <emdnDescription>ANTI-CENTROMERE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14-5505-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:16:05.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950617402770</udiDi>
    <basicUdiDi>69506174IM440262DL</basicUdiDi>
    <tradeName>06950617402770</tradeName>
    <deviceName>Anti-CENP-B Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100115</emdnCode>
    <emdnDescription>ANTI-CENTROMERE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407262</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:38:51.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950617402763</udiDi>
    <basicUdiDi>69506174IM440262DL</basicUdiDi>
    <tradeName>06950617402763</tradeName>
    <deviceName>Anti-CENP-B Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100115</emdnCode>
    <emdnDescription>ANTI-CENTROMERE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4409262</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:38:50.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950617402756</udiDi>
    <basicUdiDi>69506174IM440262DL</basicUdiDi>
    <tradeName>06950617402756</tradeName>
    <deviceName>Anti-CENP-B Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100115</emdnCode>
    <emdnDescription>ANTI-CENTROMERE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402262</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:38:44.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950617402749</udiDi>
    <basicUdiDi>69506174IM440262DL</basicUdiDi>
    <tradeName>06950617402749</tradeName>
    <deviceName>Anti-CENP-B Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100115</emdnCode>
    <emdnDescription>ANTI-CENTROMERE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403262</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:38:42.909Z</lastUpdated>
  </row>
</eudamedExport>