<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>09421028110006</udiDi>
    <basicUdiDi>942102811GMN000625</basicUdiDi>
    <tradeName>HP FEMORAL IMP/EXT W/O HANDLE</tradeName>
    <deviceName>DePuy Impactors</deviceName>
    <manufacturerName>Enztec Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000002264</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>950501171</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:25:44.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421028110013</udiDi>
    <basicUdiDi>942102811GMN000625</basicUdiDi>
    <tradeName>HP Femoral Impactor / Extractor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enztec Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000002264</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>950501220</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:25:44.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421028110044</udiDi>
    <basicUdiDi>942102811GMN000625</basicUdiDi>
    <tradeName>MBT Tibial Impactor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enztec Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000002264</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>950501558</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:25:44.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421028110051</udiDi>
    <basicUdiDi>942102811GMN000625</basicUdiDi>
    <tradeName>MBT Tibial Impactor Replacement Parts</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enztec Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000002264</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>950501559</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:25:44.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421028110198</udiDi>
    <basicUdiDi>942102811GMN002223</basicUdiDi>
    <tradeName>Offset Cup Impactor</tradeName>
    <deviceName>Minimally Invasive Hip (MIH) - Non-powered</deviceName>
    <manufacturerName>Enztec Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000002264</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIH-004-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:25:44.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421028110204</udiDi>
    <basicUdiDi>942102811GMN002223</basicUdiDi>
    <tradeName>Offset Cup Impactor Actuator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enztec Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000002264</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIH-004-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:25:44.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421028110211</udiDi>
    <basicUdiDi>942102811GMN002223</basicUdiDi>
    <tradeName>Offset Cup Impactor Anvil</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enztec Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000002264</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIH-004-04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:25:43.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421028110228</udiDi>
    <basicUdiDi>942102811GMN002223</basicUdiDi>
    <tradeName>Offset Cup Impactor Lock Ring</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enztec Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000002264</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIH-004-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:25:43.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421028110235</udiDi>
    <basicUdiDi>942102811GMN002223</basicUdiDi>
    <tradeName>Offset Cup Impactor Collet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enztec Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000002264</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIH-004-07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:25:43.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421028110242</udiDi>
    <basicUdiDi>942102811GMN002223</basicUdiDi>
    <tradeName>Offset Cup Impactor Collet Guide</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enztec Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000002264</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIH-004-08</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:25:43.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421028110259</udiDi>
    <basicUdiDi>942102811GMN002223</basicUdiDi>
    <tradeName>Offset Cup Impactor Catch Pin Assembly</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enztec Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000002264</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIH-004-16</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:25:43.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421028110266</udiDi>
    <basicUdiDi>942102811GMN002223</basicUdiDi>
    <tradeName>Offset Cup Impactor Handle Assembly</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enztec Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000002264</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIH-004-17</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:25:43.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421028110273</udiDi>
    <basicUdiDi>942102811GMN002223</basicUdiDi>
    <tradeName>Offset Cup Impactor Lever Assembly</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enztec Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000002264</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIH-004-18</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:25:43.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421028110624</udiDi>
    <basicUdiDi>942102811GMN0010ZR</basicUdiDi>
    <tradeName>Enztec Femoral Impactor - DJO</tradeName>
    <deviceName>Enztec Femoral Impactors</deviceName>
    <manufacturerName>Enztec Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000002264</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>800-05-035</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:25:43.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421028110631</udiDi>
    <basicUdiDi>942102811GMN0010ZR</basicUdiDi>
    <tradeName>DJO Femoral Impactor Head</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enztec Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000002264</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>800-05-036</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:25:43.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421028110662</udiDi>
    <basicUdiDi>942102811GMN0010ZR</basicUdiDi>
    <tradeName>Enztec Femoral Impactor - TJO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enztec Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000002264</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>2109.00.000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:25:43.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421028110679</udiDi>
    <basicUdiDi>942102811GMN0010ZR</basicUdiDi>
    <tradeName>TJO Femoral Impactor Head</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enztec Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000002264</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>2109.00.100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:25:43.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421028110785</udiDi>
    <basicUdiDi>942102811GMN001526</basicUdiDi>
    <tradeName>TJO - Universal Impactor Handle</tradeName>
    <deviceName>Impactors - General</deviceName>
    <manufacturerName>Enztec Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000002264</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>2125.00.000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:25:43.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421028110792</udiDi>
    <basicUdiDi>942102811GMN001526</basicUdiDi>
    <tradeName>TJO - Femoral Head Impactor Head</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enztec Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000002264</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>1342.00.000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:25:43.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421028110808</udiDi>
    <basicUdiDi>942102811GMN001526</basicUdiDi>
    <tradeName>TJO - All Poly Impactor Head</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Enztec Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000002264</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>2128.00.000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:25:43.490Z</lastUpdated>
  </row>
</eudamedExport>