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<eudamedExport entity="devices">
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    <udiDi>09349967002513</udiDi>
    <basicUdiDi>93499670TRNSVGNLTB47936MM</basicUdiDi>
    <tradeName>McCartney Tube™</tradeName>
    <deviceName>Tube for Trans-Vaginal Access</deviceName>
    <manufacturerName>The O R Company Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010179</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0899</emdnCode>
    <emdnDescription>GYNAECOLOGICAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>35-TV</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:06:20.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>09349967002032</udiDi>
    <basicUdiDi>93499670ANTIFOG452252T</basicUdiDi>
    <tradeName>AntiFogOR™</tradeName>
    <deviceName>Laparoscopic defogging device</deviceName>
    <manufacturerName>The O R Company Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010179</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9012</emdnCode>
    <emdnDescription>NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS003</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:06:19.861Z</lastUpdated>
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  <row>
    <udiDi>09349967001547</udiDi>
    <basicUdiDi>93499670SCPEWRMR36816W7</basicUdiDi>
    <tradeName>Scope HelpOR PRO™</tradeName>
    <deviceName>Laparoscopic cleaning and defogging device</deviceName>
    <manufacturerName>The O R Company Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010179</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9012</emdnCode>
    <emdnDescription>NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SHKPRO-02</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:06:19.065Z</lastUpdated>
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  <row>
    <udiDi>09349967001127</udiDi>
    <basicUdiDi>93499670LQDSCPEWRM63518KY</basicUdiDi>
    <tradeName>Liquid Scope WarmOR™</tradeName>
    <deviceName>Laparoscopic cleaning and defogging device</deviceName>
    <manufacturerName>The O R Company Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010179</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9012</emdnCode>
    <emdnDescription>NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS-500-M</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:06:15.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>09349967000816</udiDi>
    <basicUdiDi>93499670UTNMANPLTR58051BT</basicUdiDi>
    <tradeName>Uterine PositionOR PRO™</tradeName>
    <deviceName>Uterine Manipulator and Elevator (With or Without Tube for Trans-Vaginal Access)</deviceName>
    <manufacturerName>The O R Company Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010179</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0899</emdnCode>
    <emdnDescription>GYNAECOLOGICAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UE-PLH</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:06:14.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>09349967000458</udiDi>
    <basicUdiDi>93499670INSTHLDR45686TX</basicUdiDi>
    <tradeName>QuivOR™</tradeName>
    <deviceName>Surgical Instrument Holder</deviceName>
    <manufacturerName>The O R Company Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010179</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9012</emdnCode>
    <emdnDescription>NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>QVORSML</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:06:13.486Z</lastUpdated>
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  <row>
    <udiDi>09349967000366</udiDi>
    <basicUdiDi>93499670FASCLSRE32864ZR</basicUdiDi>
    <tradeName>Suture PassOR PRO™</tradeName>
    <deviceName>Laparoscopic Access Device / Endoscopic Access Device</deviceName>
    <manufacturerName>The O R Company Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010179</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>H0199</emdnCode>
    <emdnDescription>SURGICAL SUTURES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSG-14F</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:06:12.662Z</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>09349221000101</udiDi>
    <basicUdiDi>93492210MeridiaVL</basicUdiDi>
    <tradeName>medmont meridia™ Advanced Topographer | Professional</tradeName>
    <deviceName>Medmont Meridia Advanced Topographer</deviceName>
    <manufacturerName>Medmont International Pty.Ltd.</manufacturerName>
    <manufacturerSrn>AU-MF-000008414</manufacturerSrn>
    <authorisedRepresentativeName>PureCon bvba</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000334</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120123</emdnCode>
    <emdnDescription>COMPUTERISED CORNEAL TOPOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN003235</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:06:07.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>09349714011577</udiDi>
    <basicUdiDi>93497140MP4167KF</basicUdiDi>
    <tradeName>EP Y-Adapter Cable</tradeName>
    <deviceName>Adapter Cable Family</deviceName>
    <manufacturerName>Micropace Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000002775</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050580</emdnCode>
    <emdnDescription>CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP4157</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:06:07.078Z</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>09348498002498</udiDi>
    <basicUdiDi>93484980PHJD</basicUdiDi>
    <tradeName>PUSH HANDLE SUIT PX2</tradeName>
    <deviceName>Ferno Push Handle</deviceName>
    <manufacturerName>Ferno Australia Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000035726</manufacturerSrn>
    <authorisedRepresentativeName>Ferno S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000031265</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0880</emdnCode>
    <emdnDescription>MEDICAL SUPPORT EQUIPMENT - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FWEPHPX2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:05:49.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>09348498002344</udiDi>
    <basicUdiDi>93484980XTRIC88X</basicUdiDi>
    <tradeName>XTRIC8 Rescue Sled</tradeName>
    <deviceName>Xtric8 Rescue Sled</deviceName>
    <manufacturerName>Ferno Australia Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000035726</manufacturerSrn>
    <authorisedRepresentativeName>Ferno S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000031265</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V08050101</emdnCode>
    <emdnDescription>GENERIC USE STRETCHERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FWE-XTRIC8</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:05:48.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>09348498002160</udiDi>
    <basicUdiDi>93484980FWELSYZ</basicUdiDi>
    <tradeName>Lifesaver Confined Space Stretcher</tradeName>
    <deviceName>Lifesaver Confined Space Stretcher</deviceName>
    <manufacturerName>Ferno Australia Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000035726</manufacturerSrn>
    <authorisedRepresentativeName>Ferno S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000031265</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V08050101</emdnCode>
    <emdnDescription>GENERIC USE STRETCHERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FWELS REV.01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:05:47.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>09348498002153</udiDi>
    <basicUdiDi>93484980FWE125SF</basicUdiDi>
    <tradeName>Ferno #125 Ked PRO</tradeName>
    <deviceName>KED Pro</deviceName>
    <manufacturerName>Ferno Australia Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000035726</manufacturerSrn>
    <authorisedRepresentativeName>Ferno S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000031265</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V08050101</emdnCode>
    <emdnDescription>GENERIC USE STRETCHERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FWE125-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:05:47.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>09348498002115</udiDi>
    <basicUdiDi>93484980SXKN</basicUdiDi>
    <tradeName>Surface Xtender, Pair</tradeName>
    <deviceName>Surface Xtender</deviceName>
    <manufacturerName>Ferno Australia Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000035726</manufacturerSrn>
    <authorisedRepresentativeName>Ferno S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000031265</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0880</emdnCode>
    <emdnDescription>MEDICAL SUPPORT EQUIPMENT - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FWESX</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:05:42.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>09348498002092</udiDi>
    <basicUdiDi>93484980LHHZ</basicUdiDi>
    <tradeName>Load Frame Handles, pair</tradeName>
    <deviceName>Side Lift Handles, Load Frame Handles</deviceName>
    <manufacturerName>Ferno Australia Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000035726</manufacturerSrn>
    <authorisedRepresentativeName>Ferno S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000031265</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0880</emdnCode>
    <emdnDescription>MEDICAL SUPPORT EQUIPMENT - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FWELFH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:05:42.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>09348498002009</udiDi>
    <basicUdiDi>93484980LAIVYE</basicUdiDi>
    <tradeName>3 Stage IV Pole - Fixed Mount</tradeName>
    <deviceName>3 Stage IV Pole</deviceName>
    <manufacturerName>Ferno Australia Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000035726</manufacturerSrn>
    <authorisedRepresentativeName>Ferno S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000031265</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0880</emdnCode>
    <emdnDescription>MEDICAL SUPPORT EQUIPMENT - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAIV-3SFM</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:05:41.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>09348498001712</udiDi>
    <basicUdiDi>93484980FWEPR+ZE</basicUdiDi>
    <tradeName>FWEPR+ - Original Version</tradeName>
    <deviceName>PacRac+</deviceName>
    <manufacturerName>Ferno Australia Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000035726</manufacturerSrn>
    <authorisedRepresentativeName>Ferno S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000031265</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0880</emdnCode>
    <emdnDescription>MEDICAL SUPPORT EQUIPMENT - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FWEPR+</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:05:40.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>09348498001149</udiDi>
    <basicUdiDi>93484980BRBTLBWU</basicUdiDi>
    <tradeName>Ferno Adjustable Lifting Bridle</tradeName>
    <deviceName>Vertical Heavy Duty Lifting Bridle</deviceName>
    <manufacturerName>Ferno Australia Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000035726</manufacturerSrn>
    <authorisedRepresentativeName>Ferno S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000031265</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0805038002</emdnCode>
    <emdnDescription>NON-RIGID SUPPORTS FOR LIFTS (HARNESSES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BRB-TLB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:05:36.582Z</lastUpdated>
  </row>
</eudamedExport>