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    <basicUdiDi>B-05391529583262</basicUdiDi>
    <tradeName>Apex Femoral Nail PF Left Ø 13.0 x 480mm</tradeName>
    <deviceName>Apex Femoral Nail PF Left Ø 13.0 x 480mm</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>F01-130480</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:08:31.782Z</lastUpdated>
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    <udiDi>05391529583255</udiDi>
    <basicUdiDi>B-05391529583255</basicUdiDi>
    <tradeName>Apex Femoral Nail PF Left Ø 13.0 x 460mm</tradeName>
    <deviceName>Apex Femoral Nail PF Left Ø 13.0 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>F01-130460</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:08:30.144Z</lastUpdated>
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    <udiDi>05391529583248</udiDi>
    <basicUdiDi>B-05391529583248</basicUdiDi>
    <tradeName>Apex Femoral Nail PF Left Ø 13.0 x 440mm</tradeName>
    <deviceName>Apex Femoral Nail PF Left Ø 13.0 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>F01-130440</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:08:29.346Z</lastUpdated>
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    <udiDi>05391529583231</udiDi>
    <basicUdiDi>B-05391529583231</basicUdiDi>
    <tradeName>Apex Femoral Nail PF Left Ø 13.0 x 420mm</tradeName>
    <deviceName>Apex Femoral Nail PF Left Ø 13.0 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>F01-130420</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:08:27.737Z</lastUpdated>
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    <udiDi>05391529583224</udiDi>
    <basicUdiDi>B-05391529583224</basicUdiDi>
    <tradeName>Apex Femoral Nail PF Left Ø 12.0 x 480mm</tradeName>
    <deviceName>Apex Femoral Nail PF Left Ø 12.0 x 480mm</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>F01-120480</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:08:25.378Z</lastUpdated>
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    <udiDi>05391529583217</udiDi>
    <basicUdiDi>B-05391529583217</basicUdiDi>
    <tradeName>Apex Femoral Nail PF Left Ø 12.0 x 460mm</tradeName>
    <deviceName>Apex Femoral Nail PF Left Ø 12.0 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>F01-120460</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:08:23.740Z</lastUpdated>
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    <udiDi>05391529583200</udiDi>
    <basicUdiDi>B-05391529583200</basicUdiDi>
    <tradeName>Apex Femoral Nail PF Left Ø 12.0 x 440mm</tradeName>
    <deviceName>Apex Femoral Nail PF Left Ø 12.0 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>F01-120440</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:08:22.937Z</lastUpdated>
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    <udiDi>05391529583194</udiDi>
    <basicUdiDi>B-05391529583194</basicUdiDi>
    <tradeName>Apex Femoral Nail PF Left Ø 11.5 x 480mm</tradeName>
    <deviceName>Apex Femoral Nail PF Left Ø 11.5 x 480mm</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>F01-115480</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:08:21.451Z</lastUpdated>
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    <udiDi>05391529583187</udiDi>
    <basicUdiDi>B-05391529583187</basicUdiDi>
    <tradeName>Apex Femoral Nail PF Left Ø 11.5 x 460mm</tradeName>
    <deviceName>Apex Femoral Nail PF Left Ø 11.5 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>F01-115460</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:08:18.130Z</lastUpdated>
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  <row>
    <udiDi>05391529583170</udiDi>
    <basicUdiDi>B-05391529583170</basicUdiDi>
    <tradeName>Apex Femoral Nail PF Left Ø 11.0 x 480mm</tradeName>
    <deviceName>Apex Femoral Nail PF Left Ø 11.0 x 480mm</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>F01-110480</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:08:16.530Z</lastUpdated>
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    <udiDi>05391529583163</udiDi>
    <basicUdiDi>B-05391529583163</basicUdiDi>
    <tradeName>Apex Femoral Nail PF Left Ø 11.0 x 460mm</tradeName>
    <deviceName>Apex Femoral Nail PF Left Ø 11.0 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>F01-110460</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:08:15.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529583156</udiDi>
    <basicUdiDi>B-05391529583156</basicUdiDi>
    <tradeName>Apex Femoral Nail PF Left Ø 10.0 x 480mm</tradeName>
    <deviceName>Apex Femoral Nail PF Left Ø 10.0 x 480mm</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>F01-100480</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:08:14.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529583132</udiDi>
    <basicUdiDi>B-05391529583132</basicUdiDi>
    <tradeName>Module Connection Bolt</tradeName>
    <deviceName>Module Connection 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-1103</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:08:11.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529583118</udiDi>
    <basicUdiDi>B-05391529583118</basicUdiDi>
    <tradeName>Ø2.5x900mm Guidewire with Ball Tip</tradeName>
    <deviceName>Ø2.5x900mm Guidewire with Ball Tip</deviceName>
    <manufacturerName>OrthoXel DAC</manufacturerName>
    <manufacturerSrn>IE-MF-000000574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V9012</emdnCode>
    <emdnDescription>NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS-1069S</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:08:10.124Z</lastUpdated>
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  <row>
    <udiDi>05391529583101</udiDi>
    <basicUdiDi>B-05391529583101</basicUdiDi>
    <tradeName>Monobloc Reamer, Size 8.0</tradeName>
    <deviceName>Monobloc Reamer, Size 8.0</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‐1100</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:08:09.332Z</lastUpdated>
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    <udiDi>05391529583095</udiDi>
    <basicUdiDi>B-05391529583095</basicUdiDi>
    <tradeName>Yellow Ø4.25mm Twist Drill X Length 300mm (Use Ø5.00mm Locking Screw)</tradeName>
    <deviceName>Yellow Ø4.25mm Twist Drill X Length 300mm (Use Ø5.00mm Locking Screw)</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-1129</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:08:07.728Z</lastUpdated>
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    <udiDi>05391529583088</udiDi>
    <basicUdiDi>B-05391529583088</basicUdiDi>
    <tradeName>Monobloc Reamer, Size 7.0</tradeName>
    <deviceName>Monobloc Reamer, Size 7.0</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‐1098</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:08:05.323Z</lastUpdated>
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    <udiDi>05391529583071</udiDi>
    <basicUdiDi>B-05391529583071</basicUdiDi>
    <tradeName>Locking Screw Length Gauge (Hook)</tradeName>
    <deviceName>Locking Screw Length 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-1128</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:08:03.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391529583064</udiDi>
    <basicUdiDi>B-05391529583064</basicUdiDi>
    <tradeName>Monobloc Reamer, Size 6.0</tradeName>
    <deviceName>Monobloc Reamer, Size 6.0</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‐1096</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:08:02.927Z</lastUpdated>
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  <row>
    <udiDi>05391529583040</udiDi>
    <basicUdiDi>B-05391529583040</basicUdiDi>
    <tradeName>Modular Reamer Head, Size 16.0</tradeName>
    <deviceName>Modular Reamer Head, Size 16.0</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-1094</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:08:01.322Z</lastUpdated>
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