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<eudamedExport entity="devices">
  <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>08684798420060</udiDi>
    <basicUdiDi>B-08684798420060</basicUdiDi>
    <tradeName>REIN Single No Additive Blood Collection Tube</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-R1-1001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T19:47:32.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684798420077</udiDi>
    <basicUdiDi>B-08684798420077</basicUdiDi>
    <tradeName>REIN Twin No Additive Blood Collection Tube</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-R1-1002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T19:47:32.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684798420084</udiDi>
    <basicUdiDi>B-08684798420084</basicUdiDi>
    <tradeName>ONSET Single No Additive Blood Collection Tube</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-T1-1001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T19:47:32.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684798420091</udiDi>
    <basicUdiDi>B-08684798420091</basicUdiDi>
    <tradeName>ONSET Twin No Additive Blood Collection Tube</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-T1-1002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T19:47:32.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684798420107</udiDi>
    <basicUdiDi>B-08684798420107</basicUdiDi>
    <tradeName>PANDERMA PRP Single No Additive Blood Collection Tube</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-DE-1001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T19:47:32.142Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684798420114</udiDi>
    <basicUdiDi>B-08684798420114</basicUdiDi>
    <tradeName>PANDERMA PRP Twin No Additive Blood Collection Tube</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-DE-1002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T19:47:32.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684798420121</udiDi>
    <basicUdiDi>B-08684798420121</basicUdiDi>
    <tradeName>4T MEDICAL Single No Additive Blood Collection Tube</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-MD-1001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T19:47:32.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684798420138</udiDi>
    <basicUdiDi>B-08684798420138</basicUdiDi>
    <tradeName>4T MEDICAL Twin No Additive Blood Collection Tube</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-MD-1002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T19:47:32.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684798420145</udiDi>
    <basicUdiDi>B-08684798420145</basicUdiDi>
    <tradeName>AURACELLS AUTOLOGY EXO CAPS Single Blood Collection Tube with Sodium Citrate (Single)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-AC-0001-EC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T19:47:32.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684798420152</udiDi>
    <basicUdiDi>B-08684798420152</basicUdiDi>
    <tradeName>AURACELLS AUTOLOGY PRP/TFX (NON-GEL) Single Blood Collection Tube with Sodium Citrate (Single)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-AC-0001-TF</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T19:47:32.042Z</lastUpdated>
  </row>
</eudamedExport>