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<eudamedExport entity="devices">
  <row>
    <udiDi>04713072985033</udiDi>
    <basicUdiDi>471307298GB1FA</basicUdiDi>
    <tradeName>Vircell GS Nucleic Acid Extraction Kit</tradeName>
    <deviceName>Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>DELBIO INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000003400</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>VXGS001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:12:08.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713072985019</udiDi>
    <basicUdiDi>471307298G1QT</basicUdiDi>
    <tradeName>DELBIO Automated Nucleic Acid Analysis System</tradeName>
    <deviceName>Automated Nucleic Acid Analysis System</deviceName>
    <manufacturerName>DELBIO INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000003400</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G1-01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:12:07.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713072980939</udiDi>
    <basicUdiDi>B-04713072980939</basicUdiDi>
    <tradeName>Aposán</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DELBIO INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000003400</manufacturerSrn>
    <authorisedRepresentativeName>Delta Electronics (Netherlands) B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001692</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PULSE OXIMETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>5012733410 &amp; 5012733510</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:54.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713072980953</udiDi>
    <basicUdiDi>B-04713072980953</basicUdiDi>
    <tradeName>SPENGLER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DELBIO INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000003400</manufacturerSrn>
    <authorisedRepresentativeName>Delta Electronics (Netherlands) B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001692</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PULSE OXIMETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>5012731509</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:54.916Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713072980977</udiDi>
    <basicUdiDi>B-04713072980977</basicUdiDi>
    <tradeName>SPENGLER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DELBIO INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000003400</manufacturerSrn>
    <authorisedRepresentativeName>Delta Electronics (Netherlands) B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001692</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PULSE OXIMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5012731509</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:54.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713072980991</udiDi>
    <basicUdiDi>B-04713072980991</basicUdiDi>
    <tradeName>SPENGLER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DELBIO INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000003400</manufacturerSrn>
    <authorisedRepresentativeName>Delta Electronics (Netherlands) B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001692</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PULSE OXIMETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>5012731509</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:54.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713072985040</udiDi>
    <basicUdiDi>471307298G1QT</basicUdiDi>
    <tradeName>Vircell Molecular Analysis POC System G1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DELBIO INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000003400</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>VG1MD</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:54.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713072985057</udiDi>
    <basicUdiDi>471307298GB1FA</basicUdiDi>
    <tradeName>DELBIO GS1 Nucleic Acid Extraction Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DELBIO INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000003400</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GB-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:54.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713072985064</udiDi>
    <basicUdiDi>471307298GB1FA</basicUdiDi>
    <tradeName>DELBIO GS2 Nucleic Acid Extraction Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DELBIO INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000003400</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>GB-004</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:54.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713072985071</udiDi>
    <basicUdiDi>471307298G1QT</basicUdiDi>
    <tradeName>DELBIO Automated Nucleic Acid Analysis System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DELBIO INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000003400</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>G1-03</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:54.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713072985101</udiDi>
    <basicUdiDi>471307298GB1FA</basicUdiDi>
    <tradeName>DELBIO GS2 Nucleic Acid Extraction Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DELBIO INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000003400</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DBDIIB004E00(GB-004)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:54.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713072985118</udiDi>
    <basicUdiDi>471307298G1QT</basicUdiDi>
    <tradeName>MiniLab System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DELBIO INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000003400</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMLS</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:54.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713072985125</udiDi>
    <basicUdiDi>471307298GB1FA</basicUdiDi>
    <tradeName>GS Nucleic Acid Extraction Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DELBIO INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000003400</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VXGS001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:54.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DB110-2063K</udiDi>
    <basicUdiDi>B-DB110-2063K</basicUdiDi>
    <tradeName>D-DB110-2063K</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DELBIO INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000003400</manufacturerSrn>
    <authorisedRepresentativeName>Delta Electronics (Netherlands) B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001692</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DB110-206</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:05:39.794Z</lastUpdated>
  </row>
</eudamedExport>