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<eudamedExport entity="devices">
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    <udiDi>18904009372337</udiDi>
    <basicUdiDi>89040093BloodMonitorSC</basicUdiDi>
    <tradeName>Terumo</tradeName>
    <deviceName>Blood Collection Monitor</deviceName>
    <manufacturerName>Terumo Penpol Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000001071</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>D601</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:28:36.013Z</lastUpdated>
  </row>
  <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>
  <row>
    <udiDi>58904009330779</udiDi>
    <basicUdiDi>B-58904009330779</basicUdiDi>
    <tradeName>Terumo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terumo Penpol Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000001071</manufacturerSrn>
    <authorisedRepresentativeName>Terumo BCT Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001030</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DONOR BLOOD COLLECTION BAGS W/O FILTERS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PB-1CD156M5S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T01:05:23.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>58904009330786</udiDi>
    <basicUdiDi>B-58904009330786</basicUdiDi>
    <tradeName>Terumo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terumo Penpol Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000001071</manufacturerSrn>
    <authorisedRepresentativeName>Terumo BCT Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001030</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DONOR BLOOD COLLECTION BAGS W/O FILTERS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PB-1CD256M5S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T01:05:23.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>58904009331073</udiDi>
    <basicUdiDi>B-58904009331073</basicUdiDi>
    <tradeName>Terumo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terumo Penpol Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000001071</manufacturerSrn>
    <authorisedRepresentativeName>Terumo BCT Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001030</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DONOR BLOOD COLLECTION BAGS W/O FILTERS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PB-1CD256M8B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T01:05:23.431Z</lastUpdated>
  </row>
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    <udiDi>58904009331455</udiDi>
    <basicUdiDi>B-58904009331455</basicUdiDi>
    <tradeName>Terumo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terumo Penpol Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000001071</manufacturerSrn>
    <authorisedRepresentativeName>Terumo BCT Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001030</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BLOOD TRANSFER BAGS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PB-4TR150M8S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T01:05:23.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>58904009332254</udiDi>
    <basicUdiDi>B-58904009332254</basicUdiDi>
    <tradeName>Terumo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terumo Penpol Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000001071</manufacturerSrn>
    <authorisedRepresentativeName>Terumo BCT Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001030</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DONOR BLOOD COLLECTION TRIPLE BAGS, W/O FILTERS AND KIT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PB-3BG456M0Y</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T01:05:23.397Z</lastUpdated>
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