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<eudamedExport entity="devices">
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    <udiDi>05391529584085</udiDi>
    <basicUdiDi>53915295840856V</basicUdiDi>
    <tradeName>Tibial Targeting Guide</tradeName>
    <deviceName>Tibial Targeting Guide</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1111</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:52:41.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529584061</udiDi>
    <basicUdiDi>53915295840616F</basicUdiDi>
    <tradeName>Tibial Infrapatellar Insertion Handle</tradeName>
    <deviceName>Tibial Infrapatellar Insertion Handle</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1109</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:52:40.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529583149</udiDi>
    <basicUdiDi>53915295831496P</basicUdiDi>
    <tradeName>Large AO T-Handle</tradeName>
    <deviceName>Large AO T-Handle</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1104</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:52:40.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582890</udiDi>
    <basicUdiDi>53915295822035V</basicUdiDi>
    <tradeName>Apex Nailing System Opening and Reaming Case</tradeName>
    <deviceName>Apex Nailing System Opening and Reaming Case</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1079</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:52:36.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582852</udiDi>
    <basicUdiDi>539152958285278</basicUdiDi>
    <tradeName>Hex Driver (5mm/8mm)</tradeName>
    <deviceName>Hex Driver (5mm/8mm)</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1075</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:52:35.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582821</udiDi>
    <basicUdiDi>53915295828216V</basicUdiDi>
    <tradeName>Obturator</tradeName>
    <deviceName>Obturator</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1072</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:52:34.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582814</udiDi>
    <basicUdiDi>53915295828146Y</basicUdiDi>
    <tradeName>Modular Straight Handle</tradeName>
    <deviceName>Modular Straight Handle</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1071</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:52:33.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582807</udiDi>
    <basicUdiDi>539152958280773</basicUdiDi>
    <tradeName>Modular T-Handle</tradeName>
    <deviceName>Modular T-Handle</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1070</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:52:29.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582760</udiDi>
    <basicUdiDi>539152958276072</basicUdiDi>
    <tradeName>Mallet</tradeName>
    <deviceName>Mallet</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1065</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:52:28.203Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582753</udiDi>
    <basicUdiDi>539152958275375</basicUdiDi>
    <tradeName>Mallet Guide</tradeName>
    <deviceName>Mallet Guide</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1064</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:52:27.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582739</udiDi>
    <basicUdiDi>53915295827397B</basicUdiDi>
    <tradeName>Long Screw Driver With Retention Hex (3.5mm)</tradeName>
    <deviceName>Long Screw Driver With Retention Hex (3.5mm)</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1060</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:52:26.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582722</udiDi>
    <basicUdiDi>53915295827226S</basicUdiDi>
    <tradeName>Driver With Retention Hex (5mm)</tradeName>
    <deviceName>Driver With Retention Hex (5mm)</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1059</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:52:22.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582357</udiDi>
    <basicUdiDi>53915295823576R</basicUdiDi>
    <tradeName>Keyless Chuck</tradeName>
    <deviceName>Keyless Chuck</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1022</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:52:21.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582234</udiDi>
    <basicUdiDi>539152958223468</basicUdiDi>
    <tradeName>Combination Wrench</tradeName>
    <deviceName>Combination Wrench</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1010</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:52:20.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529581855</udiDi>
    <basicUdiDi>539152958517474</basicUdiDi>
    <tradeName>Long Removal and Insertion Hex (5mm)</tradeName>
    <deviceName>3.5mm Hex Short Driver Shaft</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1136</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:52:20.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529588656</udiDi>
    <basicUdiDi>539152958517474</basicUdiDi>
    <tradeName>Flexible Hex Driver Ball Tip (5mm/8mm)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1151</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:07:56.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529588786</udiDi>
    <basicUdiDi>53915295822035V</basicUdiDi>
    <tradeName>Long Reamer Case</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0999</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1197</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:07:56.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529588373</udiDi>
    <basicUdiDi>B-05391529588373</basicUdiDi>
    <tradeName>Apex Femoral Nail Retrograde Ø 13.0 x 300mm</tradeName>
    <deviceName>Apex Femoral Nail Retrograde Ø 13.0 x 300mm</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120201</emdnCode>
    <emdnDescription>INTRAMEDULLARY NAILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F05-130300</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:30:14.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529587536</udiDi>
    <basicUdiDi>B-05391529587536</basicUdiDi>
    <tradeName>Apex Femoral Nail GT Right Ø 14.5 x 300mm</tradeName>
    <deviceName>Apex Femoral Nail GT Right Ø 14.5 x 300mm</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120201</emdnCode>
    <emdnDescription>INTRAMEDULLARY NAILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F04-145300</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:30:12.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529587956</udiDi>
    <basicUdiDi>B-05391529587956</basicUdiDi>
    <tradeName>Apex Femoral Nail Retrograde Ø 10.0 x 420mm</tradeName>
    <deviceName>Apex Femoral Nail Retrograde Ø 10.0 x 420mm</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120201</emdnCode>
    <emdnDescription>INTRAMEDULLARY NAILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F05-100420</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:30:10.576Z</lastUpdated>
  </row>
</eudamedExport>