<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>10812747011792</udiDi>
    <basicUdiDi>081274701PLS0113M</basicUdiDi>
    <tradeName>HS PLS Bowl</tradeName>
    <deviceName>HS PLS Bowl</deviceName>
    <manufacturerName>Haemonetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000034539</manufacturerSrn>
    <authorisedRepresentativeName>Haemonetics Italia s.r.l</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000021067</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>625HS-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:14:36.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812747011761</udiDi>
    <basicUdiDi>081274701PLS0053S</basicUdiDi>
    <tradeName>PLS Harness Set</tradeName>
    <deviceName>PLS Harness Set</deviceName>
    <manufacturerName>Haemonetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000034539</manufacturerSrn>
    <authorisedRepresentativeName>Haemonetics Italia s.r.l</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000021067</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00620-CP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:14:36.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812747011686</udiDi>
    <basicUdiDi>081274701PLS0023L</basicUdiDi>
    <tradeName>BMB PLS Bowl</tradeName>
    <deviceName>Plasma Bowl</deviceName>
    <manufacturerName>Haemonetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000034539</manufacturerSrn>
    <authorisedRepresentativeName>Haemonetics Italia s.r.l</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000021067</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0625B-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:14:35.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812747011754</udiDi>
    <basicUdiDi>081274701PLS0073W</basicUdiDi>
    <tradeName>PLS HARNESS SET</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00620-00</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:14:34.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812747011242</udiDi>
    <basicUdiDi>081274701PLS0123P</basicUdiDi>
    <tradeName>PLS 2-Bags Closed Set, HS Bowl</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>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>622HS-00</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:14:32.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>10812747011198</udiDi>
    <basicUdiDi>081274701PLS0083Y</basicUdiDi>
    <tradeName>PLS 3-Bags Closed Sets, BMB</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>B030101</emdnCode>
    <emdnDescription>APHERESIS PLASMA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0623E-00</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:14:31.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>00705030000005</udiDi>
    <basicUdiDi>0705030_CELLEX_EPP_Acc_3P</basicUdiDi>
    <tradeName>Therakos Cellex Photopheresis System Procedural Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Therakos Development Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000052224</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B030204</emdnCode>
    <emdnDescription>EXTRACORPOREAL PHOTOCHAEMOTHERAPY OR PHOTOPHERESIS DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLXSP-I</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:14:01.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>10636207200317</udiDi>
    <basicUdiDi>0636207CBLB06NINVU3</basicUdiDi>
    <tradeName>PALL® STEM CELL PROCESSING SYSTEM</tradeName>
    <deviceName>PALL Stem Cell Processing System</deviceName>
    <manufacturerName>Pall International SARL</manufacturerName>
    <manufacturerSrn>CH-MF-000023177</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B0105</emdnCode>
    <emdnDescription>UMBILICAL CORD BLOOD COLLECTION, PURIFICATION, CRYOPRESERVATION BAGS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>791-02U</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:11:04.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>+M896TRU300O0</udiDi>
    <basicUdiDi>++M896TRU300OJB</basicUdiDi>
    <tradeName>Autologous Platelet Separator Disposables Kit</tradeName>
    <deviceName>Magellan® Autologous Platelet Separator Disposables Kit</deviceName>
    <manufacturerName>Arteriocyte Medical Systems, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011472</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B019003</emdnCode>
    <emdnDescription>BLOOD COMPONENTS ALIQUOTATION KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRU300-O</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:54:54.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>+M896TRU2000</udiDi>
    <basicUdiDi>++M896TRU200H8</basicUdiDi>
    <tradeName>Magellan® Autologous Platelet Separator System</tradeName>
    <deviceName>Magellan® Autologous Platelet Separator</deviceName>
    <manufacturerName>Arteriocyte Medical Systems, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011472</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B0501</emdnCode>
    <emdnDescription>PLATELET GEL AUTOMATIC PREPARATION DEVICES (EXCLUDING BAGS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRU200</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:54:54.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>+M896MRD5050</udiDi>
    <basicUdiDi>++M896MRD505BF</basicUdiDi>
    <tradeName>Ratio Dispenser Kit</tradeName>
    <deviceName>Magellan®  Ratio Dispenser Kit</deviceName>
    <manufacturerName>Arteriocyte Medical Systems, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011472</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B019003</emdnCode>
    <emdnDescription>BLOOD COMPONENTS ALIQUOTATION KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRD505</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:54:50.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>+M896MDK3050</udiDi>
    <basicUdiDi>++M896MDK3057U</basicUdiDi>
    <tradeName>Basic Platelet Separator Kit</tradeName>
    <deviceName>Magellan® Basic Platelet Separator Kit</deviceName>
    <manufacturerName>Arteriocyte Medical Systems, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011472</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B019003</emdnCode>
    <emdnDescription>BLOOD COMPONENTS ALIQUOTATION KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MDK305</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:54:49.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>+M896MDK3000</udiDi>
    <basicUdiDi>++M896MDK3007J</basicUdiDi>
    <tradeName>Autologous Platelet Separator Disposables Kit</tradeName>
    <deviceName>Magellan® Autologous Platelet Separator Disposables Kit</deviceName>
    <manufacturerName>Arteriocyte Medical Systems, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011472</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B019003</emdnCode>
    <emdnDescription>BLOOD COMPONENTS ALIQUOTATION KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MDK300</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:54:48.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>+M896MAG2000</udiDi>
    <basicUdiDi>++M896MAG2005G</basicUdiDi>
    <tradeName>Magellan Autologous Platelet Separator System</tradeName>
    <deviceName>Magellan® Autologous Platelet Separator</deviceName>
    <manufacturerName>Arteriocyte Medical Systems, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011472</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B0501</emdnCode>
    <emdnDescription>PLATELET GEL AUTOMATIC PREPARATION DEVICES (EXCLUDING BAGS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAG200</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:54:43.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>+M896BTI2000</udiDi>
    <basicUdiDi>++M896BTI2007Y</basicUdiDi>
    <tradeName>Autologous Platelet Separator System</tradeName>
    <deviceName>Magellan® Autologous Platelet Separator</deviceName>
    <manufacturerName>Arteriocyte Medical Systems, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011472</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B0501</emdnCode>
    <emdnDescription>PLATELET GEL AUTOMATIC PREPARATION DEVICES (EXCLUDING BAGS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BTI200</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:54:42.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>+M896AMSACDA0</udiDi>
    <basicUdiDi>++M896AMSACDAC3</basicUdiDi>
    <tradeName>Anticoagulant Citrate Dextrose Solution A</tradeName>
    <deviceName>Anticoagulant Citrate Dextrose Solution USP (ACD-A) Solution A</deviceName>
    <manufacturerName>Arteriocyte Medical Systems, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011472</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B07</emdnCode>
    <emdnDescription>BLOOD AND BLOOD COMPONENTS PRESERVATION SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACD-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:54:41.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>+M71223840419</udiDi>
    <basicUdiDi>++M712EXREJBK</basicUdiDi>
    <tradeName>VACUSERA</tradeName>
    <deviceName>VACUSERA EXERA REGENERATIVE KIT</deviceName>
    <manufacturerName>DİSERA TIBBİ MALZEME LOJİSTİK SAN. VE TİC. A.Ş.</manufacturerName>
    <manufacturerSrn>TR-PR-000050420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B010202</emdnCode>
    <emdnDescription>PLATELETS CONCENTRATE TRANSFER BAGS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>238404</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:54:06.355Z</lastUpdated>
  </row>
</eudamedExport>