<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07630030878572</udiDi>
    <basicUdiDi>764014274KSD0532R004L</basicUdiDi>
    <tradeName>Sphere Insert Instrument Set I5L-T5</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medacta International SA</manufacturerName>
    <manufacturerSrn>CH-MF-000033473</manufacturerSrn>
    <authorisedRepresentativeName>Medacta Italia srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000022505</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P091399</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.01025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:34.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630030842795</udiDi>
    <basicUdiDi>764014274KSD0532R004L</basicUdiDi>
    <tradeName>Insert MOBILE STD S3 Instrument Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medacta International SA</manufacturerName>
    <manufacturerSrn>CH-MF-000033473</manufacturerSrn>
    <authorisedRepresentativeName>Medacta Italia srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000022505</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P091399</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.00043</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:34.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630345730404</udiDi>
    <basicUdiDi>764014274KSD0532R004L</basicUdiDi>
    <tradeName>Sphere CR Insert Instrument Set I3L-T3+/4+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medacta International SA</manufacturerName>
    <manufacturerSrn>CH-MF-000033473</manufacturerSrn>
    <authorisedRepresentativeName>Medacta Italia srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000022505</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P091399</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.00163</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:34.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630040711685</udiDi>
    <basicUdiDi>764014274KSD0502R003K</basicUdiDi>
    <tradeName>Correction guide Instrument Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medacta International SA</manufacturerName>
    <manufacturerSrn>CH-MF-000033473</manufacturerSrn>
    <authorisedRepresentativeName>Medacta Italia srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000022505</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P091399</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.00103</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:34.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630345730398</udiDi>
    <basicUdiDi>764014274KSD0532R004L</basicUdiDi>
    <tradeName>Sphere CR Insert Instrument Set I2L-T2+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medacta International SA</manufacturerName>
    <manufacturerSrn>CH-MF-000033473</manufacturerSrn>
    <authorisedRepresentativeName>Medacta Italia srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000022505</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P091399</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.00162</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:34.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630040713948</udiDi>
    <basicUdiDi>764014274KSD0522R0049</basicUdiDi>
    <tradeName>Femoral S7 Sphere Instrument Set / No carton box</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medacta International SA</manufacturerName>
    <manufacturerSrn>CH-MF-000033473</manufacturerSrn>
    <authorisedRepresentativeName>Medacta Italia srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000022505</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P091399</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.11017</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:34.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630040714129</udiDi>
    <basicUdiDi>764014274KSD0522R0049</basicUdiDi>
    <tradeName>Femoral S6+ Sphere Instrument Set / No carton box</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medacta International SA</manufacturerName>
    <manufacturerSrn>CH-MF-000033473</manufacturerSrn>
    <authorisedRepresentativeName>Medacta Italia srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000022505</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P091399</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.11116</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:34.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630040713887</udiDi>
    <basicUdiDi>764014274KSD0522R0049</basicUdiDi>
    <tradeName>Femoral S1 Sphere Instrument Set / No carton box</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medacta International SA</manufacturerName>
    <manufacturerSrn>CH-MF-000033473</manufacturerSrn>
    <authorisedRepresentativeName>Medacta Italia srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000022505</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P091399</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.11011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:34.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630971252530</udiDi>
    <basicUdiDi>764014274KSD0532R004L</basicUdiDi>
    <tradeName>Sphere CR Insert Instrument Set I4L-T3/4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medacta International SA</manufacturerName>
    <manufacturerSrn>CH-MF-000033473</manufacturerSrn>
    <authorisedRepresentativeName>Medacta Italia srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000022505</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P091399</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.01044</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:34.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630345730169</udiDi>
    <basicUdiDi>764014274KSD0532R004L</basicUdiDi>
    <tradeName>Tibial FIXED STD-PS S4+ Instrument Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medacta International SA</manufacturerName>
    <manufacturerSrn>CH-MF-000033473</manufacturerSrn>
    <authorisedRepresentativeName>Medacta Italia srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000022505</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P091399</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.00114</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:34.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630345780553</udiDi>
    <basicUdiDi>764014274KSD0522R0049</basicUdiDi>
    <tradeName>Ultimate Sphere Femoral S4+ Instrument Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medacta International SA</manufacturerName>
    <manufacturerSrn>CH-MF-000033473</manufacturerSrn>
    <authorisedRepresentativeName>Medacta Italia srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000022505</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P091399</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.01144</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:34.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630030842801</udiDi>
    <basicUdiDi>764014274KSD0532R004L</basicUdiDi>
    <tradeName>Insert MOBILE UC S3 Instrument Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medacta International SA</manufacturerName>
    <manufacturerSrn>CH-MF-000033473</manufacturerSrn>
    <authorisedRepresentativeName>Medacta Italia srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000022505</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P091399</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.00053</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:34.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630345730435</udiDi>
    <basicUdiDi>764014274KSD0532R004L</basicUdiDi>
    <tradeName>Sphere CR Insert Instrument Set I1R-T1+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medacta International SA</manufacturerName>
    <manufacturerSrn>CH-MF-000033473</manufacturerSrn>
    <authorisedRepresentativeName>Medacta Italia srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000022505</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P091399</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.00171</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:34.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630971252608</udiDi>
    <basicUdiDi>764014274KSD0532R004L</basicUdiDi>
    <tradeName>Sphere CR Insert Instrument Set I5R-T5</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medacta International SA</manufacturerName>
    <manufacturerSrn>CH-MF-000033473</manufacturerSrn>
    <authorisedRepresentativeName>Medacta Italia srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000022505</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P091399</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.01055</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:34.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630345730473</udiDi>
    <basicUdiDi>764014274KSD0532R004L</basicUdiDi>
    <tradeName>Sphere CR Insert Instrument Set I5R-T5+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medacta International SA</manufacturerName>
    <manufacturerSrn>CH-MF-000033473</manufacturerSrn>
    <authorisedRepresentativeName>Medacta Italia srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000022505</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P091399</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.00175</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:33.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630345782298</udiDi>
    <basicUdiDi>764014274KSD0532R004L</basicUdiDi>
    <tradeName>Sphere CS-CR Insert Instrument Set I6R-T6</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medacta International SA</manufacturerName>
    <manufacturerSrn>CH-MF-000033473</manufacturerSrn>
    <authorisedRepresentativeName>Medacta Italia srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000022505</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P091399</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.01186</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:33.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630345752352</udiDi>
    <basicUdiDi>764014274KSD0552R005A</basicUdiDi>
    <tradeName>Screw L15 Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medacta International SA</manufacturerName>
    <manufacturerSrn>CH-MF-000033473</manufacturerSrn>
    <authorisedRepresentativeName>Medacta Italia srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000022505</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P091399</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.00106</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:33.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630345730770</udiDi>
    <basicUdiDi>764014274KSD0532R004L</basicUdiDi>
    <tradeName>Sphere CR Insert Instrument Set I5L-T5+/No box</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medacta International SA</manufacturerName>
    <manufacturerSrn>CH-MF-000033473</manufacturerSrn>
    <authorisedRepresentativeName>Medacta Italia srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000022505</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P091399</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.10165</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:33.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630040713818</udiDi>
    <basicUdiDi>764014274KSD0532R004L</basicUdiDi>
    <tradeName>Tibial FIXED STD S5 Instrument Set / No carton box</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medacta International SA</manufacturerName>
    <manufacturerSrn>CH-MF-000033473</manufacturerSrn>
    <authorisedRepresentativeName>Medacta Italia srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000022505</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P091399</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.10065</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:33.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630030878336</udiDi>
    <basicUdiDi>764014274KSD0532R004L</basicUdiDi>
    <tradeName>Insert MOBILE STD S7 Instrument Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medacta International SA</manufacturerName>
    <manufacturerSrn>CH-MF-000033473</manufacturerSrn>
    <authorisedRepresentativeName>Medacta Italia srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000022505</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P091399</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.00047</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:33.887Z</lastUpdated>
  </row>
</eudamedExport>