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<eudamedExport entity="devices">
  <row>
    <udiDi>08683324490218</udiDi>
    <basicUdiDi>B-08683324490218</basicUdiDi>
    <tradeName>REIN PRP Kit 1</tradeName>
    <deviceName>REIN 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-RE1-0001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:01:27.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683324490201</udiDi>
    <basicUdiDi>B-08683324490201</basicUdiDi>
    <tradeName>LIPOCUBE Six Blood Collection Tube with Sodium Citrate (Multi)</tradeName>
    <deviceName>LIPOCUBE 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-L1-0006</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:01:26.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683324490249</udiDi>
    <basicUdiDi>B-08683324490249</basicUdiDi>
    <tradeName>LIPOCUBE PRP Kit 2</tradeName>
    <deviceName>LIPOCUBE 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-CU2-0002</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:01:26.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683324490225</udiDi>
    <basicUdiDi>B-08683324490225</basicUdiDi>
    <tradeName>REIN Six Blood Collection Tube with Sodium Citrate</tradeName>
    <deviceName>REIN 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-R1-0006</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:01:25.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683324490195</udiDi>
    <basicUdiDi>B-08683324490195</basicUdiDi>
    <tradeName>LIPOCUBE PRP Kit 1</tradeName>
    <deviceName>LIPOCUBE 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-CU1-0001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:01:08.924Z</lastUpdated>
  </row>
  <row>
    <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>
</eudamedExport>