<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07290015630115</udiDi>
    <basicUdiDi>7290015630G37000100KR</basicUdiDi>
    <tradeName>BiliCare Tip Cover</tradeName>
    <deviceName>BiliCare Tip Cover</deviceName>
    <manufacturerName>Gerium Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000016697</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030101</emdnCode>
    <emdnDescription>COVER CAPS, INSTRUMENTS AND EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G37000110</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:18:35.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290015630078</udiDi>
    <basicUdiDi>72900156308200004015W</basicUdiDi>
    <tradeName>BiliWrap Wrapper</tradeName>
    <deviceName>BiliWrap Wrappers</deviceName>
    <manufacturerName>Gerium Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000016697</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>820000403</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:18:31.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290015630054</udiDi>
    <basicUdiDi>729001563082000000058</basicUdiDi>
    <tradeName>BiliWrap</tradeName>
    <deviceName>BiliWrap , Phototherapy system</deviceName>
    <manufacturerName>Gerium Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000016697</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>820000000</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:18:30.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290015630016</udiDi>
    <basicUdiDi>7290015630810002003F</basicUdiDi>
    <tradeName>BiliCare</tradeName>
    <deviceName>BiliCare</deviceName>
    <manufacturerName>Gerium Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000016697</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080410</emdnCode>
    <emdnDescription>TRANSCUTANEOUS BILIRUBINOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81000300.</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:18:30.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290017287232</udiDi>
    <basicUdiDi>B-07290017287232</basicUdiDi>
    <tradeName>PMD-200</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medasense Biometrics Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000022765</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYS-1FP-21</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:46:09.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>05281162005545</udiDi>
    <basicUdiDi>528116201PDQ5</basicUdiDi>
    <tradeName>05281162005545</tradeName>
    <deviceName>Petri Dish</deviceName>
    <manufacturerName>Plasti Lab S.A.R.L.</manufacturerName>
    <manufacturerSrn>LB-MF-000025786</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PETRI DISHES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PD-140</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:12:03.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331330512</udiDi>
    <basicUdiDi>50553313PRIWAS00005DF</basicUdiDi>
    <tradeName>BOND-PRIME Wash Solution Concentrate</tradeName>
    <deviceName>BOND-PRIME Wash Solution Concentrate</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AR0085</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:45:13.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331305121</udiDi>
    <basicUdiDi>50553313OP309700005N5</basicUdiDi>
    <tradeName>Bond Open Container 30 mL</tradeName>
    <deviceName>BOND Open Containers (30mL)</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP309700</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:44:57.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331305114</udiDi>
    <basicUdiDi>50553313OP791900005SW</basicUdiDi>
    <tradeName>Bond Open Container 7 mL</tradeName>
    <deviceName>BOND Open Containers (7mL)</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP79193</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:44:57.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331305107</udiDi>
    <basicUdiDi>50553313OPT90400005CK</basicUdiDi>
    <tradeName>BOND Titration Container 6 mL</tradeName>
    <deviceName>BOND Titration Kit</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPT9049</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:44:56.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331305091</udiDi>
    <basicUdiDi>50553313OPT97100005F3</basicUdiDi>
    <tradeName>BOND Titration Container Inserts 50 Pack</tradeName>
    <deviceName>BOND Titration Container Inserts</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPT9719</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:44:55.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331304704</udiDi>
    <basicUdiDi>50553313EMAGP1000029A</basicUdiDi>
    <tradeName>Epithelial Membrane Antigen GP1.4 7 mL</tradeName>
    <deviceName>BOND Ready-to-Use Primary Antibody Epithelial Membrane Antigen (GP1.4)</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0035</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:44:54.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331303837</udiDi>
    <basicUdiDi>50553313NEGRAB00002L5</basicUdiDi>
    <tradeName>Negative (Rabbit) 7mL</tradeName>
    <deviceName>BOND Ready-to-Use Negative Control Negative (Rabbit)</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0777</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:44:53.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331303707</udiDi>
    <basicUdiDi>50553313NEGMOU00002YB</basicUdiDi>
    <tradeName>Negative (Rabbit) 7mL</tradeName>
    <deviceName>BOND Ready-to-Use Negative Control Negative (Mouse)</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0996</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:44:53.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>09349458005597</udiDi>
    <basicUdiDi>9349458002DB</basicUdiDi>
    <tradeName>PELORIS Dual Retort Rapid Tissue Pr</tradeName>
    <deviceName></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>Artık piyasada değil</deviceStatus>
    <reference>26.0001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:53:19.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>09349458005603</udiDi>
    <basicUdiDi>9349458002DB</basicUdiDi>
    <tradeName>Peloris# Dual Retort Tissue Processor</tradeName>
    <deviceName></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>Artık piyasada değil</deviceStatus>
    <reference>26.0005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:53:19.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290016339192</udiDi>
    <basicUdiDi>B-07290016339192</basicUdiDi>
    <tradeName>WoundClot Surgical</tradeName>
    <deviceName>WoundClot Surgical</deviceName>
    <manufacturerName>Core Scientific Creations Ltd</manufacturerName>
    <manufacturerSrn>IL-MF-000008531</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M040404</emdnCode>
    <emdnDescription>CELLULOSE AND/OR MODIFIED CELLULOSE DRESSINGS, NON-COMBINED OR COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102255101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:54:11.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290014878013</udiDi>
    <basicUdiDi>7290014878BP0135V3</basicUdiDi>
    <tradeName>BioProtect Balloon Implant System</tradeName>
    <deviceName>Bioprotect Balloon Implant System</deviceName>
    <manufacturerName>BioProtect</manufacturerName>
    <manufacturerSrn>IL-MF-000013165</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0135</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:53:42.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941571800139</udiDi>
    <basicUdiDi>B-06941571800139</basicUdiDi>
    <tradeName>06941571800139</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020607</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R110-114</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:00:27.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941571800146</udiDi>
    <basicUdiDi>B-06941571800146</basicUdiDi>
    <tradeName>06941571800146</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020607</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R04-114</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:00:27.092Z</lastUpdated>
  </row>
</eudamedExport>