<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07612334241429</udiDi>
    <basicUdiDi>7611819a00662K4</basicUdiDi>
    <tradeName>VOLT</tradeName>
    <deviceName>VOLT Cortex Screws Stainless Steel</deviceName>
    <manufacturerName>Synthes GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000013345</manufacturerSrn>
    <authorisedRepresentativeName>DePuy Ireland UC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000009328</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120601</emdnCode>
    <emdnDescription>CORTICAL SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02.420.106</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:54:45.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>07612334238252</udiDi>
    <basicUdiDi>7611819a00665KA</basicUdiDi>
    <tradeName>VOLT</tradeName>
    <deviceName>VOLT Locking Screws TAV</deviceName>
    <manufacturerName>Synthes GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000013345</manufacturerSrn>
    <authorisedRepresentativeName>DePuy Ireland UC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000009328</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120601</emdnCode>
    <emdnDescription>CORTICAL SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04.420.306</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:54:41.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>07612334236951</udiDi>
    <basicUdiDi>7611819a00661K2</basicUdiDi>
    <tradeName>VOLT</tradeName>
    <deviceName>VOLT Mini Fragment Plates Commercially Pure Titanium TiCP</deviceName>
    <manufacturerName>Synthes GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000013345</manufacturerSrn>
    <authorisedRepresentativeName>DePuy Ireland UC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000009328</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120501</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS COMPRESSION PLATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04.420.001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:54:40.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>07612334235978</udiDi>
    <basicUdiDi>7611819a00812JX</basicUdiDi>
    <tradeName>VOLT</tradeName>
    <deviceName>VOLT Proximal Humerus Plates Stainless Steel</deviceName>
    <manufacturerName>Synthes GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000013345</manufacturerSrn>
    <authorisedRepresentativeName>DePuy Ireland UC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000009328</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120501</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS COMPRESSION PLATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02.538.003</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:54:39.767Z</lastUpdated>
  </row>
  <row>
    <udiDi>07612334237651</udiDi>
    <basicUdiDi>7611819a00663K6</basicUdiDi>
    <tradeName>VOLT</tradeName>
    <deviceName>VOLT Cortex Screws TAV</deviceName>
    <manufacturerName>Synthes GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000013345</manufacturerSrn>
    <authorisedRepresentativeName>DePuy Ireland UC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000009328</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120601</emdnCode>
    <emdnDescription>CORTICAL SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04.420.106</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:54:38.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>07612334235763</udiDi>
    <basicUdiDi>7611819a00658KD</basicUdiDi>
    <tradeName>VOLT</tradeName>
    <deviceName>VOLT Small Fragment Plates Stainless Steel</deviceName>
    <manufacturerName>Synthes GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000013345</manufacturerSrn>
    <authorisedRepresentativeName>DePuy Ireland UC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000009328</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120501</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS COMPRESSION PLATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02.536.010</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:54:23.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>07612334229922</udiDi>
    <basicUdiDi>7611819a00660JY</basicUdiDi>
    <tradeName>VOLT</tradeName>
    <deviceName>VOLT Mini Fragment Plates Stainless Steel</deviceName>
    <manufacturerName>Synthes GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000013345</manufacturerSrn>
    <authorisedRepresentativeName>DePuy Ireland UC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000009328</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120501</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS COMPRESSION PLATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02.420.001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:54:21.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>07612334226563</udiDi>
    <basicUdiDi>7611819a00560JT</basicUdiDi>
    <tradeName>MAXFRAME</tradeName>
    <deviceName>MaxFrame 3D II Software</deviceName>
    <manufacturerName>Synthes GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000013345</manufacturerSrn>
    <authorisedRepresentativeName>DePuy Ireland UC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000009328</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120499</emdnCode>
    <emdnDescription>EXTERNAL BONE FIXATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03.312.002</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:54:19.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>07612334210593</udiDi>
    <basicUdiDi>7611819a00761K7</basicUdiDi>
    <tradeName>07612334210593</tradeName>
    <deviceName>End Cap for Retrograde Femoral Nail</deviceName>
    <manufacturerName>Synthes GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000013345</manufacturerSrn>
    <authorisedRepresentativeName>DePuy Ireland UC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000009328</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120299</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS NAILS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04.233.000S</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:54:18.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>07612334210548</udiDi>
    <basicUdiDi>7611819a00563JZ</basicUdiDi>
    <tradeName>07612334210548</tradeName>
    <deviceName>Orthopaedic Holding Devices</deviceName>
    <manufacturerName>Synthes GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000013345</manufacturerSrn>
    <authorisedRepresentativeName>DePuy Ireland UC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000009328</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091001</emdnCode>
    <emdnDescription>INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03.233.008</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:54:16.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>07612334207968</udiDi>
    <basicUdiDi>7611819a00782KF</basicUdiDi>
    <tradeName>07612334207968</tradeName>
    <deviceName>Radial Head Replacement Instrument Kit</deviceName>
    <manufacturerName>Synthes GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000013345</manufacturerSrn>
    <authorisedRepresentativeName>DePuy Ireland UC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000009328</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12139099</emdnCode>
    <emdnDescription>VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03.405.000S</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:54:14.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>07612334170859</udiDi>
    <basicUdiDi>7611819a00551JS</basicUdiDi>
    <tradeName>07612334170859</tradeName>
    <deviceName>Suprapatellar protection sleeves for Tibia Nail Advanced</deviceName>
    <manufacturerName>Synthes GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000013345</manufacturerSrn>
    <authorisedRepresentativeName>DePuy Ireland UC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000009328</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12139099</emdnCode>
    <emdnDescription>VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03.043.007S</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:54:12.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>07612334168122</udiDi>
    <basicUdiDi>7611819a00760K5</basicUdiDi>
    <tradeName>TN-ADVANCED</tradeName>
    <deviceName>End Cap for TN-ADVANCED</deviceName>
    <manufacturerName>Synthes GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000013345</manufacturerSrn>
    <authorisedRepresentativeName>DePuy Ireland UC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000009328</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120299</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS NAILS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04.045.850S</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:54:11.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>07612334168047</udiDi>
    <basicUdiDi>7611819a00759KL</basicUdiDi>
    <tradeName>FRN-ADVANCED</tradeName>
    <deviceName>End Cap for FRN-ADVANCED</deviceName>
    <manufacturerName>Synthes GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000013345</manufacturerSrn>
    <authorisedRepresentativeName>DePuy Ireland UC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000009328</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120299</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS NAILS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04.045.800S</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:54:10.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>07612334168023</udiDi>
    <basicUdiDi>7611819a00769KP</basicUdiDi>
    <tradeName>07612334168023</tradeName>
    <deviceName>Nut and Washer</deviceName>
    <manufacturerName>Synthes GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000013345</manufacturerSrn>
    <authorisedRepresentativeName>DePuy Ireland UC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000009328</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04.045.780S</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:54:07.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>07612334167941</udiDi>
    <basicUdiDi>7611819a00601JG</basicUdiDi>
    <tradeName>07612334167941</tradeName>
    <deviceName>Orthopaedic Extraction Screw</deviceName>
    <manufacturerName>Synthes GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000013345</manufacturerSrn>
    <authorisedRepresentativeName>DePuy Ireland UC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000009328</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091001</emdnCode>
    <emdnDescription>INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03.045.030S</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:54:06.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>07612334167835</udiDi>
    <basicUdiDi>7611819a00510JC</basicUdiDi>
    <tradeName>07612334167835</tradeName>
    <deviceName>Retention Pin Stainless Steel</deviceName>
    <manufacturerName>Synthes GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000013345</manufacturerSrn>
    <authorisedRepresentativeName>DePuy Ireland UC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000009328</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12130599</emdnCode>
    <emdnDescription>MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03.045.006</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:54:04.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>07612334150684</udiDi>
    <basicUdiDi>7611819a00790KE</basicUdiDi>
    <tradeName>07612334150684</tradeName>
    <deviceName>Patella Template Kit</deviceName>
    <manufacturerName>Synthes GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000013345</manufacturerSrn>
    <authorisedRepresentativeName>DePuy Ireland UC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000009328</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12139099</emdnCode>
    <emdnDescription>VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03.137.005S</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:54:02.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>07612334143037</udiDi>
    <basicUdiDi>7611819a00603JL</basicUdiDi>
    <tradeName>07612334143037</tradeName>
    <deviceName>Drive Shaft for RIA 2</deviceName>
    <manufacturerName>Synthes GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000013345</manufacturerSrn>
    <authorisedRepresentativeName>DePuy Ireland UC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000009328</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12130599</emdnCode>
    <emdnDescription>MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03.404.035</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:54:00.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>07612334142382</udiDi>
    <basicUdiDi>7611819a00602JJ</basicUdiDi>
    <tradeName>07612334142382</tradeName>
    <deviceName>Reamer Head for RIA 2</deviceName>
    <manufacturerName>Synthes GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000013345</manufacturerSrn>
    <authorisedRepresentativeName>DePuy Ireland UC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000009328</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12130599</emdnCode>
    <emdnDescription>MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03.404.016S</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:53:58.869Z</lastUpdated>
  </row>
</eudamedExport>