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<eudamedExport entity="devices">
  <row>
    <udiDi>04718050362028</udiDi>
    <basicUdiDi>47180503600580107Z</basicUdiDi>
    <tradeName>OzTGSO HLA MX11 Typing Kit</tradeName>
    <deviceName>OzTGSO HLA MX11 Typing Kit</deviceName>
    <manufacturerName>TBG Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000029664</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>58010, 58011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:13:47.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>04718050361717</udiDi>
    <basicUdiDi>B-04718050361717</basicUdiDi>
    <tradeName>TBG ExProbe SE HLA B27 Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TBG Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000029664</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>66310</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:32:47.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>04718050361403</udiDi>
    <basicUdiDi>B-04718050361403</basicUdiDi>
    <tradeName>HLAssure SE DPB1 Locus SBT Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TBG Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000029664</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50610</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:32:46.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>04718050361380</udiDi>
    <basicUdiDi>B-04718050361380</basicUdiDi>
    <tradeName>HLAssure SE DRB1-EX Locus SBT Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TBG Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000029664</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50350</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:32:45.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>04718050361373</udiDi>
    <basicUdiDi>B-04718050361373</basicUdiDi>
    <tradeName>HLAssure SE DQB1 Locus SBT Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TBG Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000029664</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50510</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:32:44.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>04718050361366</udiDi>
    <basicUdiDi>B-04718050361366</basicUdiDi>
    <tradeName>HLAssure SE C Locus SBT Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TBG Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000029664</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50410</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:32:44.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>04718050361342</udiDi>
    <basicUdiDi>B-04718050361342</basicUdiDi>
    <tradeName>HLAssure SE B Locus SBT Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TBG Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000029664</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50210</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:32:43.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>04718050361335</udiDi>
    <basicUdiDi>B-04718050361335</basicUdiDi>
    <tradeName>HLAssure SE A Locus SBT Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TBG Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000029664</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50110</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:32:42.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>04718050360147</udiDi>
    <basicUdiDi>B-04718050360147</basicUdiDi>
    <tradeName>Morgan HLA SSP B27 Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TBG Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000029664</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>36310</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:32:41.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>04718050360123</udiDi>
    <basicUdiDi>B-04718050360123</basicUdiDi>
    <tradeName>Morgan HLA SSP DRB Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TBG Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000029664</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33280</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:32:40.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>04718050360116</udiDi>
    <basicUdiDi>B-04718050360116</basicUdiDi>
    <tradeName>Morgan HLA SSP DRB/DQB Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TBG Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000029664</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33270</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:32:39.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>04718050360109</udiDi>
    <basicUdiDi>B-04718050360109</basicUdiDi>
    <tradeName>Morgan HLA SSP C Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TBG Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000029664</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33260</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:32:38.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>04718050360093</udiDi>
    <basicUdiDi>B-04718050360093</basicUdiDi>
    <tradeName>Morgan HLA SSP B Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TBG Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000029664</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33250</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:32:37.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>04718050360086</udiDi>
    <basicUdiDi>B-04718050360086</basicUdiDi>
    <tradeName>Morgan HLA SSP A Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TBG Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000029664</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33240</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:32:36.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>04718050360062</udiDi>
    <basicUdiDi>B-04718050360062</basicUdiDi>
    <tradeName>Morgan HLA SSP DQB Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TBG Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000029664</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33290</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:32:35.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>04718050360048</udiDi>
    <basicUdiDi>B-04718050360048</basicUdiDi>
    <tradeName>Morgan HLA SSP ABDR Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TBG Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000029664</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33220, 33221, 33230, 33231</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:32:35.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>04718050360031</udiDi>
    <basicUdiDi>B-04718050360031</basicUdiDi>
    <tradeName>Morgan HLA SSP ABC Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TBG Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000029664</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33210, 33211</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:32:34.148Z</lastUpdated>
  </row>
</eudamedExport>