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<eudamedExport entity="devices">
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    <udiDi>05391529583057</udiDi>
    <basicUdiDi>B-05391529583057</basicUdiDi>
    <tradeName>Flexible IM reamer Shaft 470mm</tradeName>
    <deviceName>Flexible IM reamer Shaft 470mm</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1095</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:07:58.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529583026</udiDi>
    <basicUdiDi>B-05391529583026</basicUdiDi>
    <tradeName>Modular Reamer Head, Size 15.0</tradeName>
    <deviceName>Modular Reamer Head, Size 15.0</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1092</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:07:56.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529583033</udiDi>
    <basicUdiDi>B-05391529583033</basicUdiDi>
    <tradeName>Modular Reamer Head, Size 15.5</tradeName>
    <deviceName>Modular Reamer Head, Size 15.5</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1093</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:07:55.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529583019</udiDi>
    <basicUdiDi>B-05391529583019</basicUdiDi>
    <tradeName>Modular Reamer Head, Size 14.5</tradeName>
    <deviceName>Modular Reamer Head, Size 14.5</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1091</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:07:40.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529583002</udiDi>
    <basicUdiDi>B-05391529583002</basicUdiDi>
    <tradeName>Modular Reamer Head, Size 14.0</tradeName>
    <deviceName>Modular Reamer Head, Size 14.0</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1090</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:07:38.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582999</udiDi>
    <basicUdiDi>B-05391529582999</basicUdiDi>
    <tradeName>Modular Reamer Head, Size 13.5</tradeName>
    <deviceName>Modular Reamer Head, Size 13.5</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1089</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:07:37.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582982</udiDi>
    <basicUdiDi>B-05391529582982</basicUdiDi>
    <tradeName>Modular Reamer Head, Size 13.0</tradeName>
    <deviceName>Modular Reamer Head, Size 13.0</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1088</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:07:34.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582968</udiDi>
    <basicUdiDi>B-05391529582968</basicUdiDi>
    <tradeName>Modular Reamer Head, Size 12.0</tradeName>
    <deviceName>Modular Reamer Head, Size 12.0</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1086</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:07:33.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582951</udiDi>
    <basicUdiDi>B-05391529582951</basicUdiDi>
    <tradeName>Modular Reamer Head, Size 11.5</tradeName>
    <deviceName>Modular Reamer Head, Size 11.5</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1085</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:07:32.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582944</udiDi>
    <basicUdiDi>B-05391529582944</basicUdiDi>
    <tradeName>Modular Reamer Head, Size 11.0</tradeName>
    <deviceName>Modular Reamer Head, Size 11.0</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1084</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:07:30.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582937</udiDi>
    <basicUdiDi>B-05391529582937</basicUdiDi>
    <tradeName>Modular Reamer Head, Size 10.5</tradeName>
    <deviceName>Modular Reamer Head, Size 10.5</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1083</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:07:28.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582920</udiDi>
    <basicUdiDi>B-05391529582920</basicUdiDi>
    <tradeName>Modular Reamer Head, Size 10.0</tradeName>
    <deviceName>Modular Reamer Head, Size 10.0</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1082</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:07:26.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582913</udiDi>
    <basicUdiDi>B-05391529582913</basicUdiDi>
    <tradeName>Modular Reamer Head, Size 9.5</tradeName>
    <deviceName>Modular Reamer Head, Size 9.5</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1081</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:07:26.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582906</udiDi>
    <basicUdiDi>B-05391529582906</basicUdiDi>
    <tradeName>End Cutting Modular Reamer Head, Size 9.0</tradeName>
    <deviceName>End Cutting Modular Reamer Head, Size 9.0</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS‐1080</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:07:25.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582845</udiDi>
    <basicUdiDi>B-05391529582845</basicUdiDi>
    <tradeName>Distal Locking Screw Depth Measurement Gauge (Hook)</tradeName>
    <deviceName>Distal Locking Screw Depth Measurement Gauge (Hook)</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS‐1074</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:07:22.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582838</udiDi>
    <basicUdiDi>B-05391529582838</basicUdiDi>
    <tradeName>M12 Adapter Bolt</tradeName>
    <deviceName>M12 Adapter Bolt</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1130</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:07:19.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582791</udiDi>
    <basicUdiDi>B-05391529582791</basicUdiDi>
    <tradeName>K-Wire Ø3.2mm X Length 250mm</tradeName>
    <deviceName>K-Wire Ø3.2mm X Length 250mm</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1068</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:07:18.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582784</udiDi>
    <basicUdiDi>B-05391529582784</basicUdiDi>
    <tradeName>Apex Femoral Nailing System Case</tradeName>
    <deviceName>Apex Femoral Nailing System Case</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1067</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:07:17.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582777</udiDi>
    <basicUdiDi>B-05391529582777</basicUdiDi>
    <tradeName>Nail Extraction Bolt Ø10mm</tradeName>
    <deviceName>Nail Extraction Bolt Ø10mm</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1066</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:07:14.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582746</udiDi>
    <basicUdiDi>B-05391529582746</basicUdiDi>
    <tradeName>Opening Reamer Ø13.0mm</tradeName>
    <deviceName>Opening Reamer Ø13.0mm</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS‐1106</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:07:13.518Z</lastUpdated>
  </row>
</eudamedExport>