<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08050323150748</udiDi>
    <basicUdiDi>B-08050323150748</basicUdiDi>
    <tradeName>GKS PRIME FLEX RK: Offset Trial - 5mm</tradeName>
    <deviceName>Trial Component</deviceName>
    <manufacturerName>Permedica S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000008110</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V06010102</emdnCode>
    <emdnDescription>KNEE PROSTHESES TESTING DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S47295</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:58:18.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050323150731</udiDi>
    <basicUdiDi>B-08050323150731</basicUdiDi>
    <tradeName>GKS PRIME FLEX RK: Offset Trial - 2mm</tradeName>
    <deviceName>Trial Component</deviceName>
    <manufacturerName>Permedica S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000008110</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V06010102</emdnCode>
    <emdnDescription>KNEE PROSTHESES TESTING DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S47292</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:58:17.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050323150090</udiDi>
    <basicUdiDi>B-08050323150090</basicUdiDi>
    <tradeName>GKS PRIME FLEX PS: Trial Module for Femur Size 11-12  LEFT</tradeName>
    <deviceName>Trial Component</deviceName>
    <manufacturerName>Permedica S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000008110</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V06010102</emdnCode>
    <emdnDescription>KNEE PROSTHESES TESTING DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S47192</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:58:16.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050323150083</udiDi>
    <basicUdiDi>B-08050323150083</basicUdiDi>
    <tradeName>GKS PRIME FLEX PS: Trial Module for Femur Size 11-12  RIGHT</tradeName>
    <deviceName>Trial Component</deviceName>
    <manufacturerName>Permedica S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000008110</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V06010102</emdnCode>
    <emdnDescription>KNEE PROSTHESES TESTING DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S47191</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:58:15.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050323150076</udiDi>
    <basicUdiDi>B-08050323150076</basicUdiDi>
    <tradeName>GKS PRIME FLEX PS: Trial Module for Femur Size 9-10  LEFT</tradeName>
    <deviceName>Trial Component</deviceName>
    <manufacturerName>Permedica S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000008110</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V06010102</emdnCode>
    <emdnDescription>KNEE PROSTHESES TESTING DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S47190</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:58:11.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050323150069</udiDi>
    <basicUdiDi>B-08050323150069</basicUdiDi>
    <tradeName>GKS PRIME FLEX PS: Trial Module for Femur Size 9-10  RIGHT</tradeName>
    <deviceName>Trial Component</deviceName>
    <manufacturerName>Permedica S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000008110</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V06010102</emdnCode>
    <emdnDescription>KNEE PROSTHESES TESTING DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S47189</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:58:11.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050323150052</udiDi>
    <basicUdiDi>B-08050323150052</basicUdiDi>
    <tradeName>GKS PRIME FLEX PS: Trial Module for Femur Size 7-8  LEFT</tradeName>
    <deviceName>Trial Component</deviceName>
    <manufacturerName>Permedica S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000008110</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V06010102</emdnCode>
    <emdnDescription>KNEE PROSTHESES TESTING DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S47188</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:58:10.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050323150045</udiDi>
    <basicUdiDi>B-08050323150045</basicUdiDi>
    <tradeName>GKS PRIME FLEX PS: Trial Module for Femur Size 7-8  RIGHT</tradeName>
    <deviceName>Trial Component</deviceName>
    <manufacturerName>Permedica S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000008110</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V06010102</emdnCode>
    <emdnDescription>KNEE PROSTHESES TESTING DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S47187</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:58:09.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050323150038</udiDi>
    <basicUdiDi>B-08050323150038</basicUdiDi>
    <tradeName>GKS PRIME FLEX PS: Trial Module for Femur Size 5-6  LEFT</tradeName>
    <deviceName>Trial Component</deviceName>
    <manufacturerName>Permedica S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000008110</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V06010102</emdnCode>
    <emdnDescription>KNEE PROSTHESES TESTING DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S47186</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:58:05.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050323150021</udiDi>
    <basicUdiDi>B-08050323150021</basicUdiDi>
    <tradeName>GKS PRIME FLEX PS: Trial Module for Femur Size 5-6  RIGHT</tradeName>
    <deviceName>Trial Component</deviceName>
    <manufacturerName>Permedica S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000008110</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V06010102</emdnCode>
    <emdnDescription>KNEE PROSTHESES TESTING DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S47185</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:58:04.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050323146673</udiDi>
    <basicUdiDi>B-08050323146673</basicUdiDi>
    <tradeName>GKS PRIME FLEX RK: Trial Tibia - Size A</tradeName>
    <deviceName>Trial Component</deviceName>
    <manufacturerName>Permedica S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000008110</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V06010102</emdnCode>
    <emdnDescription>KNEE PROSTHESES TESTING DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S47770</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:58:03.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050323146666</udiDi>
    <basicUdiDi>B-08050323146666</basicUdiDi>
    <tradeName>GKS PRIME FLEX RK: Trial Tibia - Size XS</tradeName>
    <deviceName>Trial Component</deviceName>
    <manufacturerName>Permedica S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000008110</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V06010102</emdnCode>
    <emdnDescription>KNEE PROSTHESES TESTING DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S47769</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:58:03.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050323146642</udiDi>
    <basicUdiDi>B-08050323146642</basicUdiDi>
    <tradeName>GKS PRIME FLEX RK: Trial Tibial Wedge ML/LR - Size XS-A x 15mm - MAGENTA</tradeName>
    <deviceName>Trial Component</deviceName>
    <manufacturerName>Permedica S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000008110</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V06010102</emdnCode>
    <emdnDescription>KNEE PROSTHESES TESTING DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S47730</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:57:59.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050323146635</udiDi>
    <basicUdiDi>B-08050323146635</basicUdiDi>
    <tradeName>GKS PRIME FLEX RK: Trial Tibial Wedge MR/LL - Size XS-A x 15mm - MAGENTA</tradeName>
    <deviceName>Trial Component</deviceName>
    <manufacturerName>Permedica S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000008110</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V06010102</emdnCode>
    <emdnDescription>KNEE PROSTHESES TESTING DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S47729</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:57:58.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050323146628</udiDi>
    <basicUdiDi>B-08050323146628</basicUdiDi>
    <tradeName>GKS PRIME FLEX RK: Trial Tibial Wedge ML/LR - Size XS-A x 10mm - MAGENTA</tradeName>
    <deviceName>Trial Component</deviceName>
    <manufacturerName>Permedica S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000008110</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V06010102</emdnCode>
    <emdnDescription>KNEE PROSTHESES TESTING DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S47720</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:57:57.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050323146611</udiDi>
    <basicUdiDi>B-08050323146611</basicUdiDi>
    <tradeName>GKS PRIME FLEX RK: Trial Tibial Wedge MR/LL - Size XS-A x 10mm - MAGENTA</tradeName>
    <deviceName>Trial Component</deviceName>
    <manufacturerName>Permedica S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000008110</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V06010102</emdnCode>
    <emdnDescription>KNEE PROSTHESES TESTING DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S47719</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:57:55.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050323146598</udiDi>
    <basicUdiDi>B-08050323146598</basicUdiDi>
    <tradeName>GKS PRIME FLEX RK: Trial Tibial Wedge MR/LL - Size XS-A x 05mm - MAGENTA</tradeName>
    <deviceName>Trial Component</deviceName>
    <manufacturerName>Permedica S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000008110</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V06010102</emdnCode>
    <emdnDescription>KNEE PROSTHESES TESTING DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S47709</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:57:53.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050323146604</udiDi>
    <basicUdiDi>B-08050323146604</basicUdiDi>
    <tradeName>GKS PRIME FLEX RK: Trial Tibial Wedge ML/LR - Size XS-A x 05mm - MAGENTA</tradeName>
    <deviceName>Trial Component</deviceName>
    <manufacturerName>Permedica S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000008110</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V06010102</emdnCode>
    <emdnDescription>KNEE PROSTHESES TESTING DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S47710</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:57:51.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050323146574</udiDi>
    <basicUdiDi>B-08050323146574</basicUdiDi>
    <tradeName>GKS PRIME FLEX RK: Trial Tibial Baseplate - Size XS</tradeName>
    <deviceName>Trial Component</deviceName>
    <manufacturerName>Permedica S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000008110</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V06010102</emdnCode>
    <emdnDescription>KNEE PROSTHESES TESTING DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S47699</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:57:51.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050323146581</udiDi>
    <basicUdiDi>B-08050323146581</basicUdiDi>
    <tradeName>GKS PRIME FLEX RK: Trial Tibial Baseplate - Size A</tradeName>
    <deviceName>Trial Component</deviceName>
    <manufacturerName>Permedica S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000008110</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V06010102</emdnCode>
    <emdnDescription>KNEE PROSTHESES TESTING DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S47700</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:57:49.434Z</lastUpdated>
  </row>
</eudamedExport>