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<eudamedExport entity="devices">
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    <udiDi>05391529584375</udiDi>
    <basicUdiDi>B-05391529584375</basicUdiDi>
    <tradeName>Apex Tibial Nail Ø 9.0 x 255mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INTRAMEDULLARY NAILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T02-900255</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:11:45.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529584344</udiDi>
    <basicUdiDi>B-05391529584344</basicUdiDi>
    <tradeName>Apex Tibial Nail Ø 8.5 x 390mm</tradeName>
    <deviceName>Apex Tibial Nail Ø 8.5 x 390mm</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>T02-850390</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:11:43.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529584337</udiDi>
    <basicUdiDi>B-05391529584337</basicUdiDi>
    <tradeName>Apex Tibial Nail Ø 8.5 x 375mm</tradeName>
    <deviceName>Apex Tibial Nail Ø 8.5 x 375mm</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>T02-850375</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:11:42.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529584320</udiDi>
    <basicUdiDi>B-05391529584320</basicUdiDi>
    <tradeName>Apex Tibial Nail Ø 8.5 x 360mm</tradeName>
    <deviceName>Apex Tibial Nail Ø 8.5 x 360mm</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>T02-850360</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:11:41.601Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529584313</udiDi>
    <basicUdiDi>B-05391529584313</basicUdiDi>
    <tradeName>Apex Tibial Nail Ø 8.5 x 345mm</tradeName>
    <deviceName>Apex Tibial Nail Ø 8.5 x 345mm</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>T02-850345</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:11:40.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529584306</udiDi>
    <basicUdiDi>B-05391529584306</basicUdiDi>
    <tradeName>Apex Tibial Nail Ø 8.5 x 330mm</tradeName>
    <deviceName>Apex Tibial Nail Ø 8.5 x 330mm</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>T02-850330</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:11:36.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529584290</udiDi>
    <basicUdiDi>B-05391529584290</basicUdiDi>
    <tradeName>Apex Tibial Nail Ø 8.5 x 315mm</tradeName>
    <deviceName>Apex Tibial Nail Ø 8.5 x 315mm</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>T02-850315</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:11:36.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529584283</udiDi>
    <basicUdiDi>B-05391529584283</basicUdiDi>
    <tradeName>Apex Tibial Nail Ø 8.5 x 300mm</tradeName>
    <deviceName>Apex Tibial Nail Ø 8.5 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>T02-850300</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:11:35.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529584276</udiDi>
    <basicUdiDi>B-05391529584276</basicUdiDi>
    <tradeName>Apex Tibial Nail Ø 8.5 x 285mm</tradeName>
    <deviceName>Apex Tibial Nail Ø 8.5 x 285mm</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>T02-850285</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:11:34.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529584269</udiDi>
    <basicUdiDi>B-05391529584269</basicUdiDi>
    <tradeName>Apex Tibial Nail Ø 8.5 x 270mm</tradeName>
    <deviceName>Apex Tibial Nail Ø 8.5 x 270mm</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>T02-850270</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:11:30.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529584252</udiDi>
    <basicUdiDi>B-05391529584252</basicUdiDi>
    <tradeName>Apex Tibial Nail Ø 8.5 x 255mm</tradeName>
    <deviceName>Apex Tibial Nail Ø 8.5 x 255mm</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>T02-850255</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:11:29.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529584245</udiDi>
    <basicUdiDi>B-05391529584245</basicUdiDi>
    <tradeName>Yellow Ø4.25mm Drill Sleeve (Length 138.5mm)</tradeName>
    <deviceName>Yellow Ø4.25mm Drill Sleeve (Length 138.5mm)</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-1127</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:11:28.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529584238</udiDi>
    <basicUdiDi>B-05391529584238</basicUdiDi>
    <tradeName>Yellow Trocar (Length 150mm)</tradeName>
    <deviceName>Yellow Trocar (Length 150mm)</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-1126</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:11:27.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529584221</udiDi>
    <basicUdiDi>B-05391529584221</basicUdiDi>
    <tradeName>Green Outer Drill Sleeve (Length 129mm)</tradeName>
    <deviceName>Green Outer Drill Sleeve (Length 129mm)</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-1125</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:11:23.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529584214</udiDi>
    <basicUdiDi>B-05391529584214</basicUdiDi>
    <tradeName>Suprapatellar AO Mount Anchor Pin</tradeName>
    <deviceName>Suprapatellar AO Mount Anchor Pin</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-1124</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:11:23.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529584191</udiDi>
    <basicUdiDi>B-05391529584191</basicUdiDi>
    <tradeName>Suprapatellar Trocar</tradeName>
    <deviceName>Suprapatellar Trocar</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-1122</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:11:22.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529584184</udiDi>
    <basicUdiDi>B-05391529584184</basicUdiDi>
    <tradeName>Suprapatellar K-Wire Guide</tradeName>
    <deviceName>Suprapatellar K-Wire Guide</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-1121</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:11:21.599Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529584177</udiDi>
    <basicUdiDi>B-05391529584177</basicUdiDi>
    <tradeName>Suprapatellar Standard Protection Sleeve</tradeName>
    <deviceName>Suprapatellar Standard Protection Sleeve</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-1120</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:11:17.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529584160</udiDi>
    <basicUdiDi>B-05391529584160</basicUdiDi>
    <tradeName>Suprapatellar Anchoring Protection Sleeve</tradeName>
    <deviceName>Suprapatellar Anchoring Protection Sleeve</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-1119</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:11:16.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529584153</udiDi>
    <basicUdiDi>B-05391529584153</basicUdiDi>
    <tradeName>Suprapatellar Protection Sleeve Handle Connector</tradeName>
    <deviceName>Suprapatellar Protection Sleeve Handle Connector</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‐1118</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:11:16.003Z</lastUpdated>
  </row>
</eudamedExport>