<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>04547319000247</udiDi>
    <basicUdiDi>4547319FGM001_TSBPTQ</basicUdiDi>
    <tradeName>04547319000247</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FORTE GROW MEDICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000013444</manufacturerSrn>
    <authorisedRepresentativeName>Asahi Kasei Medical Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012752</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>B0380</emdnCode>
    <emdnDescription>APHERESIS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PE-FSL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:29:00.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547319000254</udiDi>
    <basicUdiDi>4547319FGM001_TSBPTQ</basicUdiDi>
    <tradeName>04547319000254</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FORTE GROW MEDICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000013444</manufacturerSrn>
    <authorisedRepresentativeName>Asahi Kasei Medical Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012752</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>B0380</emdnCode>
    <emdnDescription>APHERESIS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DFPP-FSL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:29:00.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547319000261</udiDi>
    <basicUdiDi>4547319FGM001_TSBPTQ</basicUdiDi>
    <tradeName>04547319000261</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FORTE GROW MEDICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000013444</manufacturerSrn>
    <authorisedRepresentativeName>Asahi Kasei Medical Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012752</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>B0380</emdnCode>
    <emdnDescription>APHERESIS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA-FSL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:29:00.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547319000278</udiDi>
    <basicUdiDi>4547319FGM001_TSBPTQ</basicUdiDi>
    <tradeName>04547319000278</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FORTE GROW MEDICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000013444</manufacturerSrn>
    <authorisedRepresentativeName>Asahi Kasei Medical Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012752</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>B0380</emdnCode>
    <emdnDescription>APHERESIS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS-CP</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:29:00.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547319000285</udiDi>
    <basicUdiDi>4547319FGM001_TSBPTQ</basicUdiDi>
    <tradeName>04547319000285</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FORTE GROW MEDICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000013444</manufacturerSrn>
    <authorisedRepresentativeName>Asahi Kasei Medical Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012752</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>B0380</emdnCode>
    <emdnDescription>APHERESIS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRRT-PFSL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:29:00.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547319000292</udiDi>
    <basicUdiDi>4547319FGM001_TSBPTQ</basicUdiDi>
    <tradeName>04547319000292</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FORTE GROW MEDICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000013444</manufacturerSrn>
    <authorisedRepresentativeName>Asahi Kasei Medical Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012752</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>B0380</emdnCode>
    <emdnDescription>APHERESIS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PE-PFSL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:29:00.494Z</lastUpdated>
  </row>
</eudamedExport>