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<eudamedExport entity="devices">
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    <udiDi>09349967004210</udiDi>
    <basicUdiDi>93499670SMKEEVCTOR31723LV</basicUdiDi>
    <tradeName>Laparoscopic Smoke EvacuatOR™</tradeName>
    <deviceName></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>Z12019004</emdnCode>
    <emdnDescription>SURGICAL SMOKE EVACUATION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>LSE-01</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:06:25.484Z</lastUpdated>
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  <row>
    <udiDi>09349967002933</udiDi>
    <basicUdiDi>93499670SCPECLNR38835DC</basicUdiDi>
    <tradeName>Scope CleanOR™</tradeName>
    <deviceName>Laparoscopic cleaning 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>SC-01</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:06:21.482Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <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>
  </row>
  <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>
  </row>
  <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>09349967000472</udiDi>
    <basicUdiDi>93499670INSTHLDR45686TX</basicUdiDi>
    <tradeName>QuivOR™</tradeName>
    <deviceName></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>QVORLRG</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:31.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>09349967000496</udiDi>
    <basicUdiDi>93499670INSTHLDR45686TX</basicUdiDi>
    <tradeName>QuivOR™</tradeName>
    <deviceName></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>QVORTWIN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:31.744Z</lastUpdated>
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  <row>
    <udiDi>09349967000519</udiDi>
    <basicUdiDi>93499670FASCLSRE32864ZR</basicUdiDi>
    <tradeName>Suture PassOR™</tradeName>
    <deviceName></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</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:31.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>09349967000540</udiDi>
    <basicUdiDi>93499670FASCLSRE32864ZR</basicUdiDi>
    <tradeName>Suture PassOR™</tradeName>
    <deviceName></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-XL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:31.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>09349967000571</udiDi>
    <basicUdiDi>93499670FASCLSRE32864ZR</basicUdiDi>
    <tradeName>Suture PassOR PRO™</tradeName>
    <deviceName></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-14/18F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:31.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>09349967000632</udiDi>
    <basicUdiDi>93499670FASCLSRE32864ZR</basicUdiDi>
    <tradeName>Suture PassOR PRO™</tradeName>
    <deviceName></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-18F-XL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:31.688Z</lastUpdated>
  </row>
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    <udiDi>09349967000694</udiDi>
    <basicUdiDi>93499670FASCLSRE32864ZR</basicUdiDi>
    <tradeName>Port ClosOR PRO™</tradeName>
    <deviceName></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>PC-120</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:31.669Z</lastUpdated>
  </row>
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    <udiDi>09349967000847</udiDi>
    <basicUdiDi>93499670INSTHLDR45686TX</basicUdiDi>
    <tradeName>HolstOR™</tradeName>
    <deviceName></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>H-250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:31.625Z</lastUpdated>
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  <row>
    <udiDi>09349967000861</udiDi>
    <basicUdiDi>93499670INSTHLDR45686TX</basicUdiDi>
    <tradeName>HolstOR™</tradeName>
    <deviceName></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>H-330</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:31.605Z</lastUpdated>
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    <udiDi>09349967000885</udiDi>
    <basicUdiDi>93499670INSTHLDR45686TX</basicUdiDi>
    <tradeName>HolstOR™</tradeName>
    <deviceName></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>H-410</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:31.588Z</lastUpdated>
  </row>
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    <udiDi>09349967000908</udiDi>
    <basicUdiDi>93499670UTNMANPLTR58051BT</basicUdiDi>
    <tradeName>Uterine ElevatOR PRO with Long Handle™</tradeName>
    <deviceName></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-LHPRO-32</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:31.567Z</lastUpdated>
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