<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>10812747012461</udiDi>
    <basicUdiDi>081274701MCS015XG</basicUdiDi>
    <tradeName>PLT &amp; PLS SET DOUBLE DOSE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Haemonetics S.A.</manufacturerName>
    <manufacturerSrn>CH-MF-000034549</manufacturerSrn>
    <authorisedRepresentativeName>Haemonetics Italia s.r.l</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000021067</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030104</emdnCode>
    <emdnDescription>APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>996E2-00</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:14:48.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812747012454</udiDi>
    <basicUdiDi>081274701MCS008XK</basicUdiDi>
    <tradeName>PLT &amp; PLS SET SINGLE DOSE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Haemonetics S.A.</manufacturerName>
    <manufacturerSrn>CH-MF-000034549</manufacturerSrn>
    <authorisedRepresentativeName>Haemonetics Italia s.r.l</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000021067</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030104</emdnCode>
    <emdnDescription>APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0996E-00</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:14:47.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812747012447</udiDi>
    <basicUdiDi>081274701MCS018XN</basicUdiDi>
    <tradeName>CONC PLT &amp; PLS SET W/FILTER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Haemonetics S.A.</manufacturerName>
    <manufacturerSrn>CH-MF-000034549</manufacturerSrn>
    <authorisedRepresentativeName>Haemonetics Italia s.r.l</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000021067</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030104</emdnCode>
    <emdnDescription>APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>999F-E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:14:43.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812747012430</udiDi>
    <basicUdiDi>081274701MCS003X9</basicUdiDi>
    <tradeName>PLT&amp;RBC SET W/PLT&amp;RBC FILTER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Haemonetics S.A.</manufacturerName>
    <manufacturerSrn>CH-MF-000034549</manufacturerSrn>
    <authorisedRepresentativeName>Haemonetics Italia s.r.l</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000021067</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030104</emdnCode>
    <emdnDescription>APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>949FF-E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:14:42.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812747012423</udiDi>
    <basicUdiDi>081274701MCS019XQ</basicUdiDi>
    <tradeName>PLT &amp; PLASMA SET W/FILTERS</tradeName>
    <deviceName>PLT &amp; PLASMA SET W/FILTERS</deviceName>
    <manufacturerName>Haemonetics S.A.</manufacturerName>
    <manufacturerSrn>CH-MF-000034549</manufacturerSrn>
    <authorisedRepresentativeName>Haemonetics Italia s.r.l</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000021067</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030104</emdnCode>
    <emdnDescription>APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>999FF-P-SL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:14:41.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812747012409</udiDi>
    <basicUdiDi>081274701MCS016XJ</basicUdiDi>
    <tradeName>PLT &amp; PLS SET W/FILTER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Haemonetics S.A.</manufacturerName>
    <manufacturerSrn>CH-MF-000034549</manufacturerSrn>
    <authorisedRepresentativeName>Haemonetics Italia s.r.l</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000021067</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030104</emdnCode>
    <emdnDescription>APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>997CF-E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:14:40.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812747012515</udiDi>
    <basicUdiDi>081274701MCS016XJ</basicUdiDi>
    <tradeName>PLT &amp; PLS SET W/FILTER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Haemonetics S.A.</manufacturerName>
    <manufacturerSrn>CH-MF-000034549</manufacturerSrn>
    <authorisedRepresentativeName>Haemonetics Italia s.r.l</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000021067</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030104</emdnCode>
    <emdnDescription>APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>997CF-E-CC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:50.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812747012539</udiDi>
    <basicUdiDi>081274701MCS018XN</basicUdiDi>
    <tradeName>CONC PLT &amp; PLS SET W/FILTER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Haemonetics S.A.</manufacturerName>
    <manufacturerSrn>CH-MF-000034549</manufacturerSrn>
    <authorisedRepresentativeName>Haemonetics Italia s.r.l</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000021067</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030104</emdnCode>
    <emdnDescription>APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>999F-E-CC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:50.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812747012577</udiDi>
    <basicUdiDi>081274701MCS016XJ</basicUdiDi>
    <tradeName>PLT &amp; PLS SET W/FILTER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Haemonetics S.A.</manufacturerName>
    <manufacturerSrn>CH-MF-000034549</manufacturerSrn>
    <authorisedRepresentativeName>Haemonetics Italia s.r.l</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000021067</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030104</emdnCode>
    <emdnDescription>APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>997CF-E-CN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:50.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812747012584</udiDi>
    <basicUdiDi>081274701MCS015XG</basicUdiDi>
    <tradeName>PLT &amp; PLS SET DOUBLE DOSE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Haemonetics S.A.</manufacturerName>
    <manufacturerSrn>CH-MF-000034549</manufacturerSrn>
    <authorisedRepresentativeName>Haemonetics Italia s.r.l</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000021067</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030104</emdnCode>
    <emdnDescription>APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>996E2-CN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:50.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812747012591</udiDi>
    <basicUdiDi>081274701MCS008XK</basicUdiDi>
    <tradeName>PLT &amp; PLS SET SINGLE DOSE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Haemonetics S.A.</manufacturerName>
    <manufacturerSrn>CH-MF-000034549</manufacturerSrn>
    <authorisedRepresentativeName>Haemonetics Italia s.r.l</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000021067</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030104</emdnCode>
    <emdnDescription>APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>0996E-CN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:50.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812747012607</udiDi>
    <basicUdiDi>081274701MCS016XJ</basicUdiDi>
    <tradeName>PLT&amp;PLS SET W/FILT &amp; BACT.SAMP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Haemonetics S.A.</manufacturerName>
    <manufacturerSrn>CH-MF-000034549</manufacturerSrn>
    <authorisedRepresentativeName>Haemonetics Italia s.r.l</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000021067</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030104</emdnCode>
    <emdnDescription>APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>997CF-E-BA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:50.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812747013567</udiDi>
    <basicUdiDi>081274701MCS003X9</basicUdiDi>
    <tradeName>PLT &amp; RBC SET W/PLT &amp; RBC FILTER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Haemonetics S.A.</manufacturerName>
    <manufacturerSrn>CH-MF-000034549</manufacturerSrn>
    <authorisedRepresentativeName>Haemonetics Italia s.r.l</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000021067</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030104</emdnCode>
    <emdnDescription>APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>949FF-E-CC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:37:50.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658701120</udiDi>
    <basicUdiDi>B-06970658701120</basicUdiDi>
    <tradeName>06970658701120</tradeName>
    <deviceName>Blood Component Separator</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>B030104</emdnCode>
    <emdnDescription>APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:31:39.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658700635</udiDi>
    <basicUdiDi>B-06970658700635</basicUdiDi>
    <tradeName>06970658700635</tradeName>
    <deviceName>Disposable Blood Component Apheresis Set</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>B030104</emdnCode>
    <emdnDescription>APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:31:20.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658700604</udiDi>
    <basicUdiDi>B-06970658700604</basicUdiDi>
    <tradeName>06970658700604</tradeName>
    <deviceName>Disposable Blood Component Apheresis Set</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>B030104</emdnCode>
    <emdnDescription>APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:31:19.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658700369</udiDi>
    <basicUdiDi>B-06970658700369</basicUdiDi>
    <tradeName>06970658700369</tradeName>
    <deviceName>Disposable Blood Component Apheresis Set</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>B030104</emdnCode>
    <emdnDescription>APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:31:13.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658700352</udiDi>
    <basicUdiDi>B-06970658700352</basicUdiDi>
    <tradeName>06970658700352</tradeName>
    <deviceName>Disposable Blood Component Apheresis Set</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>B030104</emdnCode>
    <emdnDescription>APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:31:12.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658700345</udiDi>
    <basicUdiDi>B-06970658700345</basicUdiDi>
    <tradeName>06970658700345</tradeName>
    <deviceName>Disposable Blood Component Apheresis Set</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>B030104</emdnCode>
    <emdnDescription>APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:31:10.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658700338</udiDi>
    <basicUdiDi>B-06970658700338</basicUdiDi>
    <tradeName>06970658700338</tradeName>
    <deviceName>Disposable Blood Component Apheresis Set</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>B030104</emdnCode>
    <emdnDescription>APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:31:09.677Z</lastUpdated>
  </row>
</eudamedExport>