<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06974318131722</udiDi>
    <basicUdiDi>697431813S-KitMW</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T7 App-D FCL SE50</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan MGI Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-001489-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T12:45:06.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974318131746</udiDi>
    <basicUdiDi>697431813S-KitMW</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T7 App-D FCL SE50</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan MGI Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-001489-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T12:44:37.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720211480270</udiDi>
    <basicUdiDi>872021148P0155H</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P015 MECP2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P015-100R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T12:44:23.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033629920321</udiDi>
    <basicUdiDi>B-08033629920321</basicUdiDi>
    <tradeName>08033629920321</tradeName>
    <deviceName>Cystic Fibrosis</deviceName>
    <manufacturerName>Nuclear Laser Medicine srl</manufacturerName>
    <manufacturerSrn>IT-MF-000025709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC023/25</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T09:14:16.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974318131876</udiDi>
    <basicUdiDi>697431813S-KitMW</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T7 App-D FCL PE150</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan MGI Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-001450-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:45:53.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974318131883</udiDi>
    <basicUdiDi>697431813S-KitMW</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T7 App-D FCL PE150</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan MGI Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-001450-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:45:52.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974318131890</udiDi>
    <basicUdiDi>697431813S-KitMW</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T7 App-D FCL PE150</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan MGI Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-001450-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:45:49.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350041434672</udiDi>
    <basicUdiDi>B-07350041434672</basicUdiDi>
    <tradeName>07350041434672</tradeName>
    <deviceName>ChromoQuant SuperSTaR Optima</deviceName>
    <manufacturerName>Cybergene AB</manufacturerName>
    <manufacturerSrn>SE-MF-000054343</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514.301-136</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:16:13.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350041434665</udiDi>
    <basicUdiDi>B-07350041434665</basicUdiDi>
    <tradeName>07350041434665</tradeName>
    <deviceName>ChromoQuant SuperSTaR Optima</deviceName>
    <manufacturerName>Cybergene AB</manufacturerName>
    <manufacturerSrn>SE-MF-000054343</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514.301-68</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:16:11.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350041434658</udiDi>
    <basicUdiDi>B-07350041434658</basicUdiDi>
    <tradeName>07350041434658</tradeName>
    <deviceName>ChromoQuant SuperSTaR Optima</deviceName>
    <manufacturerName>Cybergene AB</manufacturerName>
    <manufacturerSrn>SE-MF-000054343</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514.301-26</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:14:18.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350041434641</udiDi>
    <basicUdiDi>B-07350041434641</basicUdiDi>
    <tradeName>ChromoQuant STaR Optima 2</tradeName>
    <deviceName>ChromoQuant STaR Optima 2</deviceName>
    <manufacturerName>Cybergene AB</manufacturerName>
    <manufacturerSrn>SE-MF-000054343</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514.201-26</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:14:17.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350041434610</udiDi>
    <basicUdiDi>B-07350041434610</basicUdiDi>
    <tradeName>07350041434610</tradeName>
    <deviceName>ChromoQuant Optima XY</deviceName>
    <manufacturerName>Cybergene AB</manufacturerName>
    <manufacturerSrn>SE-MF-000054343</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010306</emdnCode>
    <emdnDescription>MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514.604-26</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:14:16.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350041434603</udiDi>
    <basicUdiDi>B-07350041434603</basicUdiDi>
    <tradeName>07350041434603</tradeName>
    <deviceName>ChromoQuant Optima 21</deviceName>
    <manufacturerName>Cybergene AB</manufacturerName>
    <manufacturerSrn>SE-MF-000054343</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010301</emdnCode>
    <emdnDescription>DOWN'S SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514.603-26</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:14:12.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350041434597</udiDi>
    <basicUdiDi>B-07350041434597</basicUdiDi>
    <tradeName>07350041434597</tradeName>
    <deviceName>ChromoQuant Optima 18</deviceName>
    <manufacturerName>Cybergene AB</manufacturerName>
    <manufacturerSrn>SE-MF-000054343</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010302</emdnCode>
    <emdnDescription>EDWARDS SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514.602-26</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:14:11.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350041434580</udiDi>
    <basicUdiDi>B-07350041434580</basicUdiDi>
    <tradeName>07350041434580</tradeName>
    <deviceName>ChromoQuant Optima 13</deviceName>
    <manufacturerName>Cybergene AB</manufacturerName>
    <manufacturerSrn>SE-MF-000054343</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010304</emdnCode>
    <emdnDescription>PÄTAU SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514.601-26</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:14:10.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350041434573</udiDi>
    <basicUdiDi>B-07350041434573</basicUdiDi>
    <tradeName>07350041434573</tradeName>
    <deviceName>ChromoQuant STaR Optima 1</deviceName>
    <manufacturerName>Cybergene AB</manufacturerName>
    <manufacturerSrn>SE-MF-000054343</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514.100-136</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:14:10.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350041434566</udiDi>
    <basicUdiDi>B-07350041434566</basicUdiDi>
    <tradeName>07350041434566</tradeName>
    <deviceName>ChromoQuant Optima PLUS</deviceName>
    <manufacturerName>Cybergene AB</manufacturerName>
    <manufacturerSrn>SE-MF-000054343</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010306</emdnCode>
    <emdnDescription>MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>513.001-26</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:14:06.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350041434511</udiDi>
    <basicUdiDi>B-07350041434511</basicUdiDi>
    <tradeName>07350041434511</tradeName>
    <deviceName>STaR Optima 1</deviceName>
    <manufacturerName>Cybergene AB</manufacturerName>
    <manufacturerSrn>SE-MF-000054343</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010306</emdnCode>
    <emdnDescription>MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514.100-68</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:14:05.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350041434504</udiDi>
    <basicUdiDi>B-07350041434504</basicUdiDi>
    <tradeName>07350041434504</tradeName>
    <deviceName>STaR Optima 1</deviceName>
    <manufacturerName>Cybergene AB</manufacturerName>
    <manufacturerSrn>SE-MF-000054343</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010306</emdnCode>
    <emdnDescription>MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514.100-26</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:14:04.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350041433408</udiDi>
    <basicUdiDi>B-07350041433408</basicUdiDi>
    <tradeName>07350041433408</tradeName>
    <deviceName>ChromoQuant AZF</deviceName>
    <manufacturerName>Cybergene AB</manufacturerName>
    <manufacturerSrn>SE-MF-000054343</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800.001-32</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:14:03.640Z</lastUpdated>
  </row>
</eudamedExport>