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<eudamedExport entity="devices">
  <row>
    <udiDi>05020583260085</udiDi>
    <basicUdiDi>5020583TRACIIQZ</basicUdiDi>
    <tradeName>T-RAC II -Wifi</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terumo BCT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001069</manufacturerSrn>
    <authorisedRepresentativeName>Terumo BCT Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001030</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030199</emdnCode>
    <emdnDescription>APHERESIS COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-TRAC2W</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:16:00.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>05020583700406</udiDi>
    <basicUdiDi>5020583OptiaWastE2</basicUdiDi>
    <tradeName>Accessory Waste Bag</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terumo BCT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001069</manufacturerSrn>
    <authorisedRepresentativeName>Terumo BCT Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001030</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>APHERESIS COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70040</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:15:58.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>05020583213005</udiDi>
    <basicUdiDi>5020583RikaBotPL</basicUdiDi>
    <tradeName>Rika Plasma Bottle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terumo BCT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001069</manufacturerSrn>
    <authorisedRepresentativeName>Terumo BCT Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001030</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>APHERESIS COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>21300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:15:56.677Z</lastUpdated>
  </row>
  <row>
    <udiDi>05020583212008</udiDi>
    <basicUdiDi>5020583RikaSetRB</basicUdiDi>
    <tradeName>Rika Plasma Separation Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terumo BCT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001069</manufacturerSrn>
    <authorisedRepresentativeName>Terumo BCT Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001030</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>APHERESIS COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>21200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:15:55.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>05020583122000</udiDi>
    <basicUdiDi>5020583OptiaSPDCSetNC</basicUdiDi>
    <tradeName>Spectra Optia™ SPD-C Connection Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terumo BCT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001069</manufacturerSrn>
    <authorisedRepresentativeName>Terumo BCT Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001030</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>APHERESIS COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12200</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:15:55.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>05020583112216</udiDi>
    <basicUdiDi>5020583ACAdapterPG</basicUdiDi>
    <tradeName>Spectra Optia™ Anticoagulant Adaptor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terumo BCT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001069</manufacturerSrn>
    <authorisedRepresentativeName>Terumo BCT Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001030</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>APHERESIS COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11221</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:15:54.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>05020583112209</udiDi>
    <basicUdiDi>5020583OptiaSNConnectorH5</basicUdiDi>
    <tradeName>Spectra Optia™ Single Needle Connector</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terumo BCT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001069</manufacturerSrn>
    <authorisedRepresentativeName>Terumo BCT Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001030</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>APHERESIS COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11220</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:15:53.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>05020583102200</udiDi>
    <basicUdiDi>5020583OptiaExchBF</basicUdiDi>
    <tradeName>Spectra Optia™ Exchange Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terumo BCT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001069</manufacturerSrn>
    <authorisedRepresentativeName>Terumo BCT Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001030</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>APHERESIS COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10220</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:15:52.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>05020583001299</udiDi>
    <basicUdiDi>5020583TRACIIAccessoryFP</basicUdiDi>
    <tradeName>TRAC II High Energy Battery XLR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terumo BCT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001069</manufacturerSrn>
    <authorisedRepresentativeName>Terumo BCT Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001030</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030199</emdnCode>
    <emdnDescription>APHERESIS COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME+05TRC320</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:15:51.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>05020583122208</udiDi>
    <basicUdiDi>5020583OptiaExchBF</basicUdiDi>
    <tradeName>Spectra Optia™ Exchange Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terumo BCT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001069</manufacturerSrn>
    <authorisedRepresentativeName>Terumo BCT Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001030</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>APHERESIS COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12220</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:32:22.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>05020583260115</udiDi>
    <basicUdiDi>5020583TRACIIAccessoryFP</basicUdiDi>
    <tradeName>T-RAC II Transport Case</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terumo BCT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001069</manufacturerSrn>
    <authorisedRepresentativeName>Terumo BCT Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001030</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>B030199</emdnCode>
    <emdnDescription>APHERESIS COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-TRAC203</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:32:22.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>05020583620216</udiDi>
    <basicUdiDi>5020583TRACIIAccessoryFP</basicUdiDi>
    <tradeName>TRAC II Quad Charger</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terumo BCT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001069</manufacturerSrn>
    <authorisedRepresentativeName>Terumo BCT Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001030</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>B030199</emdnCode>
    <emdnDescription>APHERESIS COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-TRAC207</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T21:54:01.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>05020583620117</udiDi>
    <basicUdiDi>5020583TRACIIAccessoryFP</basicUdiDi>
    <tradeName>TRAC II Multifunctional Pole V2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terumo BCT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001069</manufacturerSrn>
    <authorisedRepresentativeName>Terumo BCT Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001030</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>B030199</emdnCode>
    <emdnDescription>APHERESIS COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-TRAC204</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T21:54:01.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>05020583260108</udiDi>
    <basicUdiDi>5020583TRACIIAccessoryFP</basicUdiDi>
    <tradeName>T-RAC II Desktop Remote Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terumo BCT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001069</manufacturerSrn>
    <authorisedRepresentativeName>Terumo BCT Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001030</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>B030199</emdnCode>
    <emdnDescription>APHERESIS COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-TRAC202</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T21:53:59.256Z</lastUpdated>
  </row>
</eudamedExport>