<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00852059007116</udiDi>
    <basicUdiDi>B-00852059007116</basicUdiDi>
    <tradeName>Transpose Ultra</tradeName>
    <deviceName>Transpose Ultra</deviceName>
    <manufacturerName>InGeneron Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040203</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V901699</emdnCode>
    <emdnDescription>SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11188-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:22:13.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850071153255</udiDi>
    <basicUdiDi>B-00850071153255</basicUdiDi>
    <tradeName>00850071153255</tradeName>
    <deviceName>Sonablate</deviceName>
    <manufacturerName>Focus Surgery, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012164</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120610</emdnCode>
    <emdnDescription>ULTRASOUND THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Sonablate</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:04:03.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850040712216</udiDi>
    <basicUdiDi>B-00850040712216</basicUdiDi>
    <tradeName>HemaSure</tradeName>
    <deviceName>HemaSure-OMICS Blood Stabilization Direct Draw Tube, 250 ul</deviceName>
    <manufacturerName>Mawi DNA Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023207</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0501010199</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HemaSure-OMICS-250</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:48.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850040712209</udiDi>
    <basicUdiDi>B-00850040712209</basicUdiDi>
    <tradeName>HemaSure</tradeName>
    <deviceName>HemaSure-OMICS Blood Stabilization Direct Draw device, 9ml</deviceName>
    <manufacturerName>Mawi DNA Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023207</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0501010199</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HemaSure-OMICS-9</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:48.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850040712193</udiDi>
    <basicUdiDi>B-00850040712193</basicUdiDi>
    <tradeName>HemaSure</tradeName>
    <deviceName>HemaSure-OMICS Blood Stabilization Direct Draw device, 6ml</deviceName>
    <manufacturerName>Mawi DNA Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023207</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0501010199</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HemaSure-OMICS-6</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:44.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850040712186</udiDi>
    <basicUdiDi>B-00850040712186</basicUdiDi>
    <tradeName>HemaSure</tradeName>
    <deviceName>HemaSure-OMICS Blood Stabilization Direct Draw device, 3ml</deviceName>
    <manufacturerName>Mawi DNA Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023207</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0501010199</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HemaSure-OMICS-3</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:43.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817238010042</udiDi>
    <basicUdiDi>B-00817238010042</basicUdiDi>
    <tradeName>00817238010042</tradeName>
    <deviceName>Cardiac Marker Control VS</deviceName>
    <manufacturerName>Cliniqa Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023908</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91474</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:04:09.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811331010695</udiDi>
    <basicUdiDi>B-00811331010695</basicUdiDi>
    <tradeName>TZ Defibrillation Electrode</tradeName>
    <deviceName>TZ Defibrillation Electrode</deviceName>
    <manufacturerName>TZ Medical inc</manufacturerName>
    <manufacturerSrn>US-MF-000027311</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030585</emdnCode>
    <emdnDescription>DEFIBRILLATORS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P-211-z1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:41:51.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811331010688</udiDi>
    <basicUdiDi>B-00811331010688</basicUdiDi>
    <tradeName>TZ DEFIBRILLATOR ELECTRODES</tradeName>
    <deviceName>TZ DEFIBRILLATOR ELECTRODES</deviceName>
    <manufacturerName>TZ Medical inc</manufacturerName>
    <manufacturerSrn>US-MF-000027311</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030585</emdnCode>
    <emdnDescription>DEFIBRILLATORS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P-311-T1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:41:51.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>09359011000006</udiDi>
    <basicUdiDi>93590110GKC20XXEH</basicUdiDi>
    <tradeName>PKG System</tradeName>
    <deviceName>The Parkinsons KinetiGraph (PKG) System</deviceName>
    <manufacturerName>GKC Manufacturing Pty. Ltd.</manufacturerName>
    <manufacturerSrn>AU-MF-000021150</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12062599</emdnCode>
    <emdnDescription>KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PKG System</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:08:22.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>09349458000004</udiDi>
    <basicUdiDi>9349458001D9</basicUdiDi>
    <tradeName>BOND-III Processing Module Laboratory - Automated Slide Stainer</tradeName>
    <deviceName>BOND Processing Module</deviceName>
    <manufacturerName>Leica Biosystems Melbourne Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000016740</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059002</emdnCode>
    <emdnDescription>AUTOMATED SLIDE STAINERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21.2201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:06:08.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>09349458004712</udiDi>
    <basicUdiDi>9349458002DB</basicUdiDi>
    <tradeName>Spaced Basket Kit</tradeName>
    <deviceName>HistoCore PELORIS</deviceName>
    <manufacturerName>Leica Biosystems Melbourne Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000016740</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059010</emdnCode>
    <emdnDescription>TISSUE PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S45.4503</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:06:06.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908022258008</udiDi>
    <basicUdiDi>8908022258AVAXX9G</basicUdiDi>
    <tradeName>08908022258008</tradeName>
    <deviceName>Ventilators</deviceName>
    <manufacturerName>AgVa Healthcare</manufacturerName>
    <manufacturerSrn>IN-MF-000036367</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010504</emdnCode>
    <emdnDescription>ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:08:15.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>89043812010147</udiDi>
    <basicUdiDi>89043812MALELATEXCONDOMFU</basicUdiDi>
    <tradeName>Kruidvat Classic x 12</tradeName>
    <deviceName>NATURAL RUBBER MALE LATEX CONDOM</deviceName>
    <manufacturerName>INDUS MEDICARE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000008912</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U110101</emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KVT230</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:39:06.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>08881300376017</udiDi>
    <basicUdiDi>888130037600GL</basicUdiDi>
    <tradeName>UNAwheel Mini</tradeName>
    <deviceName>UNAwheel</deviceName>
    <manufacturerName>UNAcare Pte.Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000008153</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y122410</emdnCode>
    <emdnDescription>ELECTRIC PROPULSION UNIT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UWM640602</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:08:05.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>00877067000324</udiDi>
    <basicUdiDi>87706700FPRD-021UL</basicUdiDi>
    <tradeName>Dermadry - LARGE CASE</tradeName>
    <deviceName>Dermadry - Large Briefcase</deviceName>
    <manufacturerName>Dermadry Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000025789</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120604</emdnCode>
    <emdnDescription>IONTOPHORESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FPRD-021</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:13:26.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>00877067000300</udiDi>
    <basicUdiDi>87706700FPRD-019UZ</basicUdiDi>
    <tradeName>Dermadry - UNDERARM ELECTRODES</tradeName>
    <deviceName>Dermadry -Underarm electrodes</deviceName>
    <manufacturerName>Dermadry Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000025789</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120604</emdnCode>
    <emdnDescription>IONTOPHORESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FPRD-019</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:13:22.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>00877067000294</udiDi>
    <basicUdiDi>87706700FPRD-018UX</basicUdiDi>
    <tradeName>Dermadry - TOWELS</tradeName>
    <deviceName>Dermadry -Towels</deviceName>
    <manufacturerName>Dermadry Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000025789</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120604</emdnCode>
    <emdnDescription>IONTOPHORESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FPRD-018</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:13:21.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>00877067000287</udiDi>
    <basicUdiDi>87706700FPRD-017UV</basicUdiDi>
    <tradeName>Dermadry - HANDS &amp; FEET ELECTRODES</tradeName>
    <deviceName>Dermadry - Hands and Feet Electrodes</deviceName>
    <manufacturerName>Dermadry Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000025789</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120604</emdnCode>
    <emdnDescription>IONTOPHORESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FPRD-017</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:13:21.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>00877067000256</udiDi>
    <basicUdiDi>87706700DERMADRY58</basicUdiDi>
    <tradeName>Dermadry - Total - EN/FR/DE/SP/IT/NL Europe</tradeName>
    <deviceName>Dermadry</deviceName>
    <manufacturerName>Dermadry Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000025789</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120604</emdnCode>
    <emdnDescription>IONTOPHORESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FPRD-052</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:13:20.377Z</lastUpdated>
  </row>
</eudamedExport>