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    <tradeName>Mako</tradeName>
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    <manufacturerName>MAKO Surgical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000000703</manufacturerSrn>
    <authorisedRepresentativeName>Stryker European Operations Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000092</authorisedRepresentativeSrn>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:47.349Z</lastUpdated>
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    <udiDi>08050323166220</udiDi>
    <basicUdiDi>B-08050323166220</basicUdiDi>
    <tradeName>GKS PRIME FLEX RK: Trial Tibia v2 - Size E</tradeName>
    <deviceName>Trial Component</deviceName>
    <manufacturerName>Permedica S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000008110</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>S47846</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:07:51.134Z</lastUpdated>
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    <udiDi>08050323166213</udiDi>
    <basicUdiDi>B-08050323166213</basicUdiDi>
    <tradeName>GKS PRIME FLEX RK: Trial Tibia v2 - Size C</tradeName>
    <deviceName>Trial Component</deviceName>
    <manufacturerName>Permedica S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000008110</manufacturerSrn>
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    <emdnDescription>KNEE PROSTHESES TESTING DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S47844</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:07:50.344Z</lastUpdated>
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    <basicUdiDi>B-08050323166237</basicUdiDi>
    <tradeName>GKS PRIME FLEX RK: Trial Tibia v2 - Size F</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>S47847</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:07:48.831Z</lastUpdated>
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    <udiDi>08050323166206</udiDi>
    <basicUdiDi>B-08050323166206</basicUdiDi>
    <tradeName>GKS PRIME FLEX RK: Trial Tibia v2 - Size B</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>S47843</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:07:35.074Z</lastUpdated>
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    <udiDi>08050323166190</udiDi>
    <basicUdiDi>B-08050323166190</basicUdiDi>
    <tradeName>GKS BUTTERFLY: Trial Femoral sleeve - ANTILUXATION</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>S42036</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:07:31.066Z</lastUpdated>
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    <udiDi>08050323166183</udiDi>
    <basicUdiDi>B-08050323166183</basicUdiDi>
    <tradeName>GKS BUTTERFLY: Trial Femoral sleeve - STANDARD</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>S42035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:07:30.283Z</lastUpdated>
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    <udiDi>08050323166176</udiDi>
    <basicUdiDi>B-08050323166176</basicUdiDi>
    <tradeName>GKS BUTTERFLY: Antiluxation Tibial Trial Insert - SMALL 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>S42034</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:07:29.482Z</lastUpdated>
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    <udiDi>08050323166169</udiDi>
    <basicUdiDi>B-08050323166169</basicUdiDi>
    <tradeName>GKS BUTTERFLY: Antiluxation Tibial Trial Insert - SMALL 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>S42033</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:07:28.683Z</lastUpdated>
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    <udiDi>08050323166152</udiDi>
    <basicUdiDi>B-08050323166152</basicUdiDi>
    <tradeName>GKS BUTTERFLY: Antiluxation Tibial Trial Insert - MEDIUM 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>S42032</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:07:24.664Z</lastUpdated>
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    <udiDi>08050323166145</udiDi>
    <basicUdiDi>B-08050323166145</basicUdiDi>
    <tradeName>GKS BUTTERFLY: Antiluxation Tibial Trial Insert - MEDIUM 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>S42031</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:07:23.862Z</lastUpdated>
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    <udiDi>08050323165940</udiDi>
    <basicUdiDi>B-08050323165940</basicUdiDi>
    <tradeName>GKS PRIME FLEX RK: TRIAL STEM - Ø 14x125mm</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>S47345</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:07:23.085Z</lastUpdated>
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    <udiDi>08050323165933</udiDi>
    <basicUdiDi>B-08050323165933</basicUdiDi>
    <tradeName>GKS PRIME FLEX RK: TRIAL STEM - Ø 13x125mm</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>S47344</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:07:22.265Z</lastUpdated>
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    <udiDi>08050323165926</udiDi>
    <basicUdiDi>B-08050323165926</basicUdiDi>
    <tradeName>GKS PRIME FLEX RK: TRIAL STEM - Ø 12x125mm</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>S47343</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:07:18.260Z</lastUpdated>
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    <udiDi>08050323165919</udiDi>
    <basicUdiDi>B-08050323165919</basicUdiDi>
    <tradeName>GKS PRIME FLEX RK: TRIAL STEM - Ø 11x125mm</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>S47342</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:07:17.563Z</lastUpdated>
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    <udiDi>08050323165902</udiDi>
    <basicUdiDi>B-08050323165902</basicUdiDi>
    <tradeName>GKS PRIME FLEX RK: TRIAL STEM - Ø 10x125mm</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>S47341</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:07:17.464Z</lastUpdated>
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    <udiDi>08050323165896</udiDi>
    <basicUdiDi>B-08050323165896</basicUdiDi>
    <tradeName>GKS PRIME FLEX RK: TRIAL STEM - Ø 24x85mm</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>S47335</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:07:17.459Z</lastUpdated>
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    <udiDi>08050323165889</udiDi>
    <basicUdiDi>B-08050323165889</basicUdiDi>
    <tradeName>GKS PRIME FLEX RK: TRIAL STEM - Ø 22x85mm</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>S47333</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:07:11.953Z</lastUpdated>
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    <udiDi>08050323165872</udiDi>
    <basicUdiDi>B-08050323165872</basicUdiDi>
    <tradeName>GKS PRIME FLEX RK: TRIAL STEM - Ø 15x85mm</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>S47326</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:07:11.270Z</lastUpdated>
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    <udiDi>08050323165865</udiDi>
    <basicUdiDi>B-08050323165865</basicUdiDi>
    <tradeName>GKS PRIME FLEX RK: TRIAL STEM - Ø 13x85mm</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>S47324</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:07:10.387Z</lastUpdated>
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