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    <udiDi>08809975010401</udiDi>
    <basicUdiDi>9975010371DL</basicUdiDi>
    <tradeName>cobas IGRA TB tubes</tradeName>
    <deviceName>cobas IGRA TB tubes</deviceName>
    <manufacturerName>Invitros Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000023980</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050101010201</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09989978190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:26:49.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IFC0002K00AR</udiDi>
    <basicUdiDi>B-IFC0002K00AR</basicUdiDi>
    <tradeName>AdvanSure™ i3 TB-IGRA Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Invitros Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000023980</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFC0002K00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T13:34:43.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IFR0002K00KN</udiDi>
    <basicUdiDi>B-IFR0002K00KN</basicUdiDi>
    <tradeName>AdvanSure™ i3 TB-IGRA Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Invitros Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000023980</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFR0002K00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T13:34:43.589Z</lastUpdated>
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  <row>
    <udiDi>08809975010050</udiDi>
    <basicUdiDi>B-08809975010050</basicUdiDi>
    <tradeName>AdvanSure™ AlloScreen Max 108 Panel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Invitros Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000023980</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MXB0060K00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T03:39:14.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809975010173</udiDi>
    <basicUdiDi>B-08809975010173</basicUdiDi>
    <tradeName>AdvanSure™ i3 TB-IGRA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Invitros Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000023980</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFI0040K00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T03:41:53.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809975010319</udiDi>
    <basicUdiDi>B-08809975010319</basicUdiDi>
    <tradeName>AdvanSure™ TB-IGRA ELISA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Invitros Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000023980</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TBE0001K00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T03:41:53.124Z</lastUpdated>
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  <row>
    <udiDi>08800050290459</udiDi>
    <basicUdiDi>B-08800050290459</basicUdiDi>
    <tradeName>AdvanSure™ AlloScreen Max108 Panel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Invitros Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000023980</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MXB0060K00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T16:51:42.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800050290589</udiDi>
    <basicUdiDi>B-08800050290589</basicUdiDi>
    <tradeName>cobas IGRA SARS-CoV-2 Tubes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Invitros Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000023980</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9542507190</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T16:51:42.575Z</lastUpdated>
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