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<eudamedExport entity="devices">
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    <udiDi>05391529582500</udiDi>
    <basicUdiDi>B-05391529582500</basicUdiDi>
    <tradeName>Multi-Lumen K-Wire Guide</tradeName>
    <deviceName>Multi-Lumen 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-1037</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:06:25.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582494</udiDi>
    <basicUdiDi>B-05391529582494</basicUdiDi>
    <tradeName>K-Wire Ø3.2mm X Length 350mm</tradeName>
    <deviceName>K-Wire Ø3.2mm X Length 350mm</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-1036</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:06:25.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582487</udiDi>
    <basicUdiDi>B-05391529582487</basicUdiDi>
    <tradeName>Nail Length Gauge</tradeName>
    <deviceName>Nail Length Gauge</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‐1035</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:06:23.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582425</udiDi>
    <basicUdiDi>B-05391529582425</basicUdiDi>
    <tradeName>Closed-end ratchet wrench</tradeName>
    <deviceName>Closed-end ratchet wrench</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-1029</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:06:20.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582364</udiDi>
    <basicUdiDi>B-05391529582364</basicUdiDi>
    <tradeName>Skin Protector</tradeName>
    <deviceName>Skin Protector</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-1023</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:06:18.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582272</udiDi>
    <basicUdiDi>B-05391529582272</basicUdiDi>
    <tradeName>Slide Hammer</tradeName>
    <deviceName>Slide Hammer</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-1014</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:06:17.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582258</udiDi>
    <basicUdiDi>B-05391529582258</basicUdiDi>
    <tradeName>Supine Driver</tradeName>
    <deviceName>Supine Driver</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-1012</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:06:16.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582241</udiDi>
    <basicUdiDi>B-05391529582241</basicUdiDi>
    <tradeName>Reamer / Nail Diameter Length Gauge</tradeName>
    <deviceName>Reamer / Nail Diameter Length Gauge</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-1011</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:06:13.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582227</udiDi>
    <basicUdiDi>B-05391529582227</basicUdiDi>
    <tradeName>Locking Screw Driver</tradeName>
    <deviceName>Locking Screw Driver</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-1008</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:06:12.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582210</udiDi>
    <basicUdiDi>B-05391529582210</basicUdiDi>
    <tradeName>Endcap Driver</tradeName>
    <deviceName>Endcap Driver</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-1007</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:06:11.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582203</udiDi>
    <basicUdiDi>B-05391529582203</basicUdiDi>
    <tradeName>Apex Tibial Nail System Tray 1</tradeName>
    <deviceName>Apex Tibial Nail System Tray 1</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-1006</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:06:09.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582180</udiDi>
    <basicUdiDi>B-05391529582180</basicUdiDi>
    <tradeName>Tibial Nail Extraction Bolt</tradeName>
    <deviceName>Tibial Nail Extraction 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-1004</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:06:07.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582173</udiDi>
    <basicUdiDi>B-05391529582173</basicUdiDi>
    <tradeName>Apex Antegrade Femoral Locking Endcap 0mm Length</tradeName>
    <deviceName>Apex Antegrade Femoral Locking Endcap 0mm Length</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>LE02-000</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:06:06.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582159</udiDi>
    <basicUdiDi>B-05391529582159</basicUdiDi>
    <tradeName>Apex Antegrade Femoral Endcap 15mm length</tradeName>
    <deviceName>Apex Antegrade Femoral Endcap 15mm length</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>E02-015</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:06:04.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582142</udiDi>
    <basicUdiDi>B-05391529582142</basicUdiDi>
    <tradeName>Apex Antegrade Femoral Endcap 10mm Length</tradeName>
    <deviceName>Apex Antegrade Femoral Endcap 10mm Length</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>E02-010</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:06:02.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582111</udiDi>
    <basicUdiDi>B-05391529582111</basicUdiDi>
    <tradeName>Apex Femoral Nail PF Right Ø 10.0 x 460mm</tradeName>
    <deviceName>Apex Femoral Nail PF Right Ø 10.0 x 460mm</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>F02-100460</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:06:00.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582135</udiDi>
    <basicUdiDi>B-05391529582135</basicUdiDi>
    <tradeName>Apex Antegrade Femoral Endcap 5mm Length</tradeName>
    <deviceName>Apex Antegrade Femoral Endcap 5mm Length</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>E02-005</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:05:57.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582128</udiDi>
    <basicUdiDi>B-05391529582128</basicUdiDi>
    <tradeName>Apex Antegrade Femoral Endcap 0mm Length</tradeName>
    <deviceName>Apex Antegrade Femoral Endcap 0mm Length</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>E02-000</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:05:57.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582104</udiDi>
    <basicUdiDi>B-05391529582104</basicUdiDi>
    <tradeName>Apex Femoral Nail PF Right Ø 10.0 x 440mm</tradeName>
    <deviceName>Apex Femoral Nail PF Right Ø 10.0 x 440mm</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>F02-100440</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:05:55.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529582098</udiDi>
    <basicUdiDi>B-05391529582098</basicUdiDi>
    <tradeName>Apex Femoral Nail PF Right Ø 10.0 x 420mm</tradeName>
    <deviceName>Apex Femoral Nail PF Right 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>F02-100420</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:05:39.488Z</lastUpdated>
  </row>
</eudamedExport>