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<eudamedExport entity="devices">
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    <udiDi>08683324490188</udiDi>
    <basicUdiDi>B-08683324490188</basicUdiDi>
    <tradeName>ORIG-IN Six Blood Collection Tube with Sodium Citrate (Multi)</tradeName>
    <deviceName>ORIG-IN Six Blood Collection Tube with Sodium Citrate (Multi)</deviceName>
    <manufacturerName>KAIZEN ENDUSTRI SANAYI VE DIŞ TIC.LTD.ŞTI.</manufacturerName>
    <manufacturerSrn>TR-MF-000024428</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-ORG-0006</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:01:07.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683324490171</udiDi>
    <basicUdiDi>B-08683324490171</basicUdiDi>
    <tradeName>DR-U Six Blood Collection Tube with Sodium Citrate (Multi)</tradeName>
    <deviceName>DR-U Six Blood Collection Tube with Sodium Citrate (Multi)</deviceName>
    <manufacturerName>KAIZEN ENDUSTRI SANAYI VE DIŞ TIC.LTD.ŞTI.</manufacturerName>
    <manufacturerSrn>TR-MF-000024428</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-D1-0006</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:01:06.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683324490164</udiDi>
    <basicUdiDi>B-08683324490164</basicUdiDi>
    <tradeName>A-GAIN Six Blood Collection Tube with Sodium Citrate (Multi)</tradeName>
    <deviceName>A-GAIN Six Blood Collection Tube with Sodium Citrate (Multi)</deviceName>
    <manufacturerName>KAIZEN ENDUSTRI SANAYI VE DIŞ TIC.LTD.ŞTI.</manufacturerName>
    <manufacturerSrn>TR-MF-000024428</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-A1-0006</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:01:06.127Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683324490157</udiDi>
    <basicUdiDi>B-08683324490157</basicUdiDi>
    <tradeName>SELF-AID Six Blood Collection Tube with Sodium Citrate (Multi)</tradeName>
    <deviceName>SELF-AID Six Blood Collection Tube with Sodium Citrate (Multi)</deviceName>
    <manufacturerName>KAIZEN ENDUSTRI SANAYI VE DIŞ TIC.LTD.ŞTI.</manufacturerName>
    <manufacturerSrn>TR-MF-000024428</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-SLF1-0006</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:01:02.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683324490140</udiDi>
    <basicUdiDi>B-08683324490140</basicUdiDi>
    <tradeName>ONSET Six Blood Collection Tube with Sodium Citrate (Multi)</tradeName>
    <deviceName>ONSET Six Blood Collection Tube with Sodium Citrate (Multi)</deviceName>
    <manufacturerName>KAIZEN ENDUSTRI SANAYI VE DIŞ TIC.LTD.ŞTI.</manufacturerName>
    <manufacturerSrn>TR-MF-000024428</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-T1-0006</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:01:01.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683324490133</udiDi>
    <basicUdiDi>B-08683324490133</basicUdiDi>
    <tradeName>U4U Six Blood Collection Tube with Sodium Citrate (Multi)</tradeName>
    <deviceName>U4U Six Blood Collection Tube with Sodium Citrate (Multi)</deviceName>
    <manufacturerName>KAIZEN ENDUSTRI SANAYI VE DIŞ TIC.LTD.ŞTI.</manufacturerName>
    <manufacturerSrn>TR-MF-000024428</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-U1-0006</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:01:00.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683324490126</udiDi>
    <basicUdiDi>B-08683324490126</basicUdiDi>
    <tradeName>ORIG-IN PRP Kit 2</tradeName>
    <deviceName>ORIG-IN PRP Kit 2</deviceName>
    <manufacturerName>KAIZEN ENDUSTRI SANAYI VE DIŞ TIC.LTD.ŞTI.</manufacturerName>
    <manufacturerSrn>TR-MF-000024428</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-IN2-0002</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:00:59.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683324490119</udiDi>
    <basicUdiDi>B-08683324490119</basicUdiDi>
    <tradeName>DR-U PRP Kit 2</tradeName>
    <deviceName>DR-U PRP Kit 2</deviceName>
    <manufacturerName>KAIZEN ENDUSTRI SANAYI VE DIŞ TIC.LTD.ŞTI.</manufacturerName>
    <manufacturerSrn>TR-MF-000024428</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-DR2-0002</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:00:55.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683324490102</udiDi>
    <basicUdiDi>B-08683324490102</basicUdiDi>
    <tradeName>A-GAIN PRP Kit 2</tradeName>
    <deviceName>A-GAIN PRP Kit 2</deviceName>
    <manufacturerName>KAIZEN ENDUSTRI SANAYI VE DIŞ TIC.LTD.ŞTI.</manufacturerName>
    <manufacturerSrn>TR-MF-000024428</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-GN2-0002</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:00:54.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683324490096</udiDi>
    <basicUdiDi>B-08683324490096</basicUdiDi>
    <tradeName>SELF-AID PRP Kit 2</tradeName>
    <deviceName>SELF-AID PRP Kit 2</deviceName>
    <manufacturerName>KAIZEN ENDUSTRI SANAYI VE DIŞ TIC.LTD.ŞTI.</manufacturerName>
    <manufacturerSrn>TR-MF-000024428</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-AID2-0002</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:00:54.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683324490089</udiDi>
    <basicUdiDi>B-08683324490089</basicUdiDi>
    <tradeName>ONSET PRP Kit 2</tradeName>
    <deviceName>ONSET PRP Kit 2</deviceName>
    <manufacturerName>KAIZEN ENDUSTRI SANAYI VE DIŞ TIC.LTD.ŞTI.</manufacturerName>
    <manufacturerSrn>TR-MF-000024428</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-K2-0002</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:00:53.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683324490072</udiDi>
    <basicUdiDi>B-08683324490072</basicUdiDi>
    <tradeName>U4U PRP Kit 2</tradeName>
    <deviceName>U4U PRP Kit 2</deviceName>
    <manufacturerName>KAIZEN ENDUSTRI SANAYI VE DIŞ TIC.LTD.ŞTI.</manufacturerName>
    <manufacturerSrn>TR-MF-000024428</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-FR2-0002</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:00:49.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683324490065</udiDi>
    <basicUdiDi>B-08683324490065</basicUdiDi>
    <tradeName>ORIG-IN PRP Kit 1</tradeName>
    <deviceName>ORIG-IN PRP Kit 1</deviceName>
    <manufacturerName>KAIZEN ENDUSTRI SANAYI VE DIŞ TIC.LTD.ŞTI.</manufacturerName>
    <manufacturerSrn>TR-MF-000024428</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-IN1-0001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:00:48.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683324490058</udiDi>
    <basicUdiDi>B-08683324490058</basicUdiDi>
    <tradeName>DR-U PRP Kit 1</tradeName>
    <deviceName>DR-U PRP Kit 1</deviceName>
    <manufacturerName>KAIZEN ENDUSTRI SANAYI VE DIŞ TIC.LTD.ŞTI.</manufacturerName>
    <manufacturerSrn>TR-MF-000024428</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-DR1-0001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:00:48.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683324490041</udiDi>
    <basicUdiDi>B-08683324490041</basicUdiDi>
    <tradeName>A-GAIN PRP Kit 1</tradeName>
    <deviceName>A-GAIN PRP Kit 1</deviceName>
    <manufacturerName>KAIZEN ENDUSTRI SANAYI VE DIŞ TIC.LTD.ŞTI.</manufacturerName>
    <manufacturerSrn>TR-MF-000024428</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-GN1-0001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:00:48.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683324490034</udiDi>
    <basicUdiDi>B-08683324490034</basicUdiDi>
    <tradeName>SELF-AID PRP Kit 1</tradeName>
    <deviceName>SELF-AID PRP Kit 1</deviceName>
    <manufacturerName>KAIZEN ENDUSTRI SANAYI VE DIŞ TIC.LTD.ŞTI.</manufacturerName>
    <manufacturerSrn>TR-MF-000024428</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-AID1-0001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:00:43.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683324490027</udiDi>
    <basicUdiDi>B-08683324490027</basicUdiDi>
    <tradeName>ONSET PRP Kit 1</tradeName>
    <deviceName>ONSET PRP Kit 1</deviceName>
    <manufacturerName>KAIZEN ENDUSTRI SANAYI VE DIŞ TIC.LTD.ŞTI.</manufacturerName>
    <manufacturerSrn>TR-MF-000024428</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-K1-0001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:00:42.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683324490010</udiDi>
    <basicUdiDi>B-08683324490010</basicUdiDi>
    <tradeName>U4U PRP Kit 1</tradeName>
    <deviceName>U4U PRP Kit 1</deviceName>
    <manufacturerName>KAIZEN ENDUSTRI SANAYI VE DIŞ TIC.LTD.ŞTI.</manufacturerName>
    <manufacturerSrn>TR-MF-000024428</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-FR1-0001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:00:41.313Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701556402504</udiDi>
    <basicUdiDi>37015564PERFUSIONN5</basicUdiDi>
    <tradeName>SET DE PREPARATION DE DEBRANCHEMENT VVP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INNOSET</manufacturerName>
    <manufacturerSrn>FR-PR-000001655</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B0380</emdnCode>
    <emdnDescription>APHERESIS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>073803</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:52:17.496Z</lastUpdated>
  </row>
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    <udiDi>08681049536600</udiDi>
    <basicUdiDi>B-08681049536600</basicUdiDi>
    <tradeName>Disposet</tradeName>
    <deviceName>Cryobag</deviceName>
    <manufacturerName>DİSPOSET TIBBİ ÜRÜNLER SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000018945</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B0103</emdnCode>
    <emdnDescription>MEDULLARY BLOOD COLLECTION, PURIFICATION, CRYOPRESERVATION BAGS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>925-0750</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T09:40:27.719Z</lastUpdated>
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</eudamedExport>