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<eudamedExport entity="devices">
  <row>
    <udiDi>06924464103708</udiDi>
    <basicUdiDi>69244641004TE</basicUdiDi>
    <tradeName>HBH</tradeName>
    <deviceName>PRP tube with anticoagulant</deviceName>
    <manufacturerName>BEIJING HANBAIHAN MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028967</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU-PRP(G)-05</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:25:00.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924464103500</udiDi>
    <basicUdiDi>69244641005TG</basicUdiDi>
    <tradeName>06924464103500</tradeName>
    <deviceName>PRP Kit with anticoagulant</deviceName>
    <manufacturerName>BEIJING HANBAIHAN MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028967</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU-PRP(G)-08A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:24:59.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924464103210</udiDi>
    <basicUdiDi>69244641001T8</basicUdiDi>
    <tradeName>06924464103210</tradeName>
    <deviceName>PRP tube without anticoagulant</deviceName>
    <manufacturerName>BEIJING HANBAIHAN MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028967</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU-PRN(G)-N05</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:24:55.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924464103012</udiDi>
    <basicUdiDi>69244641002TA</basicUdiDi>
    <tradeName>06924464103012</tradeName>
    <deviceName>PRP kit without anticoagulant</deviceName>
    <manufacturerName>BEIJING HANBAIHAN MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028967</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU-PRN(G)-08A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:24:54.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>05054638102266</udiDi>
    <basicUdiDi>5054638OptiaExchMF</basicUdiDi>
    <tradeName>Spectra Optia™ Exchange Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Terumo BCT, Ltd.</manufacturerName>
    <manufacturerSrn>XI-MF-000004232</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030199</emdnCode>
    <emdnDescription>APHERESIS COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>10226</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:07:56.285Z</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>B030199</emdnCode>
    <emdnDescription>APHERESIS COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70040</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:53:07.288Z</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>B030199</emdnCode>
    <emdnDescription>APHERESIS COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>21300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:53:03.270Z</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>B030199</emdnCode>
    <emdnDescription>APHERESIS COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>21200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:53:02.472Z</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>B030199</emdnCode>
    <emdnDescription>APHERESIS COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12200</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:53:01.674Z</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>B030199</emdnCode>
    <emdnDescription>APHERESIS COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11221</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:53:00.871Z</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>B030199</emdnCode>
    <emdnDescription>APHERESIS COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11220</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:52:56.905Z</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>B030199</emdnCode>
    <emdnDescription>APHERESIS COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10220</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:52:56.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658701144</udiDi>
    <basicUdiDi>B-06970658701144</basicUdiDi>
    <tradeName>06970658701144</tradeName>
    <deviceName>Blood Cell Processor</deviceName>
    <manufacturerName>Sichuan Nigale Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030199</emdnCode>
    <emdnDescription>APHERESIS COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T22:34:22.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924464103579</udiDi>
    <basicUdiDi>69244641005TG</basicUdiDi>
    <tradeName>06924464103579</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BEIJING HANBAIHAN MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028967</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU-PRP(G)-10D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:35.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924464103586</udiDi>
    <basicUdiDi>69244641005TG</basicUdiDi>
    <tradeName>06924464103586</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BEIJING HANBAIHAN MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028967</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU-PRP(G)-12A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:34.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924464103593</udiDi>
    <basicUdiDi>69244641005TG</basicUdiDi>
    <tradeName>06924464103593</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BEIJING HANBAIHAN MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028967</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU-PRP(G)-12B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:34.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924464103609</udiDi>
    <basicUdiDi>69244641005TG</basicUdiDi>
    <tradeName>06924464103609</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BEIJING HANBAIHAN MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028967</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU-PRP(G)-12C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:34.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924464103616</udiDi>
    <basicUdiDi>69244641005TG</basicUdiDi>
    <tradeName>06924464103616</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BEIJING HANBAIHAN MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028967</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU-PRP(G)-12D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:34.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924464103623</udiDi>
    <basicUdiDi>69244641005TG</basicUdiDi>
    <tradeName>06924464103623</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BEIJING HANBAIHAN MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028967</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU-PRP(G)-20A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:33.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924464103630</udiDi>
    <basicUdiDi>69244641005TG</basicUdiDi>
    <tradeName>06924464103630</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BEIJING HANBAIHAN MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028967</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU-PRP(G)-20B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:33.459Z</lastUpdated>
  </row>
</eudamedExport>