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<eudamedExport entity="devices">
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    <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>07640137442842</udiDi>
    <basicUdiDi>B-07640137442842</basicUdiDi>
    <tradeName>Granopen 050</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INFOMED SA</manufacturerName>
    <manufacturerSrn>CH-MF-000021686</manufacturerSrn>
    <authorisedRepresentativeName>INFOMED SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LF-050-00</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:43:04.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640137442835</udiDi>
    <basicUdiDi>B-07640137442835</basicUdiDi>
    <tradeName>INUSpherese filter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INFOMED SA</manufacturerName>
    <manufacturerSrn>CH-MF-000021686</manufacturerSrn>
    <authorisedRepresentativeName>INFOMED SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FR-200-90</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:42:59.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640137442415</udiDi>
    <basicUdiDi>B-07640137442415</basicUdiDi>
    <tradeName>07640137442415</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INFOMED SA</manufacturerName>
    <manufacturerSrn>CH-MF-000021686</manufacturerSrn>
    <authorisedRepresentativeName>INFOMED SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TL-306-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:42:27.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640137442118</udiDi>
    <basicUdiDi>B-07640137442118</basicUdiDi>
    <tradeName>Medopen 30</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INFOMED SA</manufacturerName>
    <manufacturerSrn>CH-MF-000021686</manufacturerSrn>
    <authorisedRepresentativeName>INFOMED SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FR-200-30</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:42:21.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640137442101</udiDi>
    <basicUdiDi>B-07640137442101</basicUdiDi>
    <tradeName>Medopen 10</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INFOMED SA</manufacturerName>
    <manufacturerSrn>CH-MF-000021686</manufacturerSrn>
    <authorisedRepresentativeName>INFOMED SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FR-200-10</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:42:20.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640137441852</udiDi>
    <basicUdiDi>B-07640137441852</basicUdiDi>
    <tradeName>Granopen 060</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INFOMED SA</manufacturerName>
    <manufacturerSrn>CH-MF-000021686</manufacturerSrn>
    <authorisedRepresentativeName>INFOMED SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LF-060-00</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:42:19.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640137441364</udiDi>
    <basicUdiDi>B-07640137441364</basicUdiDi>
    <tradeName>Tuline 320</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INFOMED SA</manufacturerName>
    <manufacturerSrn>CH-MF-000021686</manufacturerSrn>
    <authorisedRepresentativeName>INFOMED SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TU-320-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:42:15.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640137441050</udiDi>
    <basicUdiDi>B-07640137441050</basicUdiDi>
    <tradeName>Granopen 050</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INFOMED SA</manufacturerName>
    <manufacturerSrn>CH-MF-000021686</manufacturerSrn>
    <authorisedRepresentativeName>INFOMED SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LF-050-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:42:06.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640137441043</udiDi>
    <basicUdiDi>B-07640137441043</basicUdiDi>
    <tradeName>Granopen 030</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INFOMED SA</manufacturerName>
    <manufacturerSrn>CH-MF-000021686</manufacturerSrn>
    <authorisedRepresentativeName>INFOMED SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LF-030-00</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:42:01.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640137440824</udiDi>
    <basicUdiDi>B-07640137440824</basicUdiDi>
    <tradeName>TULINE 306</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INFOMED SA</manufacturerName>
    <manufacturerSrn>CH-MF-000021686</manufacturerSrn>
    <authorisedRepresentativeName>INFOMED SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B030201</emdnCode>
    <emdnDescription>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TU-306-00</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:41:41.223Z</lastUpdated>
  </row>
</eudamedExport>