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    <manufacturerName>ORTHO PAUHER INDUSTRIA COMERCIO E DISTRIBUICOES LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000055005</manufacturerSrn>
    <authorisedRepresentativeName>Rápido e Contínuo Unipessoal LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000039288</authorisedRepresentativeSrn>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T19:35:11.773Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>ORTHO PAUHER INDUSTRIA COMERCIO E DISTRIBUICOES LTDA</manufacturerName>
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    <tradeName>BRA FOR BREAST PROSTHESIS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHO PAUHER INDUSTRIA COMERCIO E DISTRIBUICOES LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000055005</manufacturerSrn>
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    <tradeName>3/4 SILIGEL INSOLE WITH PILOT AND BLUE SPOT</tradeName>
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    <manufacturerName>ORTHO PAUHER INDUSTRIA COMERCIO E DISTRIBUICOES LTDA</manufacturerName>
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    <authorisedRepresentativeName>Rápido e Contínuo Unipessoal LDA</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T19:34:50.516Z</lastUpdated>
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    <udiDi>07898415010874</udiDi>
    <basicUdiDi>789994730046V</basicUdiDi>
    <tradeName>3/4 SILIGEL INSOLE WITH PILOT AND BLUE SPOT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHO PAUHER INDUSTRIA COMERCIO E DISTRIBUICOES LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000055005</manufacturerSrn>
    <authorisedRepresentativeName>Rápido e Contínuo Unipessoal LDA</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5002</reference>
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    <lastUpdated>2026-07-07T19:34:50.323Z</lastUpdated>
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    <udiDi>07898415010881</udiDi>
    <basicUdiDi>789994730046V</basicUdiDi>
    <tradeName>3/4 SILIGEL INSOLE WITH PILOT AND BLUE SPOT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHO PAUHER INDUSTRIA COMERCIO E DISTRIBUICOES LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000055005</manufacturerSrn>
    <authorisedRepresentativeName>Rápido e Contínuo Unipessoal LDA</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T19:34:50.166Z</lastUpdated>
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    <udiDi>07898415010904</udiDi>
    <basicUdiDi>789994730046V</basicUdiDi>
    <tradeName>3/4 SILIGEL INSOLE WITH PILOT AND BLUE SPOT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHO PAUHER INDUSTRIA COMERCIO E DISTRIBUICOES LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000055005</manufacturerSrn>
    <authorisedRepresentativeName>Rápido e Contínuo Unipessoal LDA</authorisedRepresentativeName>
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    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-07T19:34:50.009Z</lastUpdated>
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    <udiDi>07898415010911</udiDi>
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    <tradeName>3/4 SILIGEL INSOLE WITH PILOT AND BLUE SPOT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHO PAUHER INDUSTRIA COMERCIO E DISTRIBUICOES LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000055005</manufacturerSrn>
    <authorisedRepresentativeName>Rápido e Contínuo Unipessoal LDA</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T19:34:49.933Z</lastUpdated>
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    <udiDi>07898415010928</udiDi>
    <basicUdiDi>789994730046V</basicUdiDi>
    <tradeName>3/4 SILIGEL INSOLE WITH PILOT AND BLUE SPOT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHO PAUHER INDUSTRIA COMERCIO E DISTRIBUICOES LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000055005</manufacturerSrn>
    <authorisedRepresentativeName>Rápido e Contínuo Unipessoal LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000039288</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T19:34:49.666Z</lastUpdated>
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    <udiDi>07898415014414</udiDi>
    <basicUdiDi>789994730046V</basicUdiDi>
    <tradeName>ANTI-IMPACT INSOLE SILICALK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHO PAUHER INDUSTRIA COMERCIO E DISTRIBUICOES LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000055005</manufacturerSrn>
    <authorisedRepresentativeName>Rápido e Contínuo Unipessoal LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000039288</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SK04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T19:34:49.048Z</lastUpdated>
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    <udiDi>07898415014421</udiDi>
    <basicUdiDi>789994730046V</basicUdiDi>
    <tradeName>ANTI-IMPACT INSOLE SILICALK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHO PAUHER INDUSTRIA COMERCIO E DISTRIBUICOES LTDA</manufacturerName>
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    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SK04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T19:34:48.919Z</lastUpdated>
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    <tradeName>ANTI-IMPACT INSOLE SILICALK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHO PAUHER INDUSTRIA COMERCIO E DISTRIBUICOES LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000055005</manufacturerSrn>
    <authorisedRepresentativeName>Rápido e Contínuo Unipessoal LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000039288</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SK04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <tradeName>ANTI-IMPACT INSOLE SILICALK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHO PAUHER INDUSTRIA COMERCIO E DISTRIBUICOES LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000055005</manufacturerSrn>
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    <authorisedRepresentativeSrn>PT-AR-000039288</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SK04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T19:34:48.800Z</lastUpdated>
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    <basicUdiDi>789994730046V</basicUdiDi>
    <tradeName>ANTI-IMPACT INSOLE SILICALK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHO PAUHER INDUSTRIA COMERCIO E DISTRIBUICOES LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000055005</manufacturerSrn>
    <authorisedRepresentativeName>Rápido e Contínuo Unipessoal LDA</authorisedRepresentativeName>
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    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
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    <placedOnMarketCountry></placedOnMarketCountry>
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    <tradeName>ANTI-IMPACT INSOLE SILICALK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHO PAUHER INDUSTRIA COMERCIO E DISTRIBUICOES LTDA</manufacturerName>
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    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T19:34:48.432Z</lastUpdated>
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    <udiDi>07898415014308</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>ORTHO PAUHER INDUSTRIA COMERCIO E DISTRIBUICOES LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000055005</manufacturerSrn>
    <authorisedRepresentativeName>Rápido e Contínuo Unipessoal LDA</authorisedRepresentativeName>
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    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
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    <reference>SK03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T19:34:48.176Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>ORTHO PAUHER INDUSTRIA COMERCIO E DISTRIBUICOES LTDA</manufacturerName>
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    <authorisedRepresentativeName>Rápido e Contínuo Unipessoal LDA</authorisedRepresentativeName>
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    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SK03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T19:34:48.074Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>ORTHO PAUHER INDUSTRIA COMERCIO E DISTRIBUICOES LTDA</manufacturerName>
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    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
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    <placedOnMarketCountry></placedOnMarketCountry>
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    <tradeName>INSOLE WITH ARCH SILICALK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ORTHO PAUHER INDUSTRIA COMERCIO E DISTRIBUICOES LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000055005</manufacturerSrn>
    <authorisedRepresentativeName>Rápido e Contínuo Unipessoal LDA</authorisedRepresentativeName>
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    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
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    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>07898258291089</udiDi>
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    <tradeName>Sterile Intragastric Balloon</tradeName>
    <deviceName>STERILE INTRAGASTRIC BALLOON</deviceName>
    <manufacturerName>Medicone Projetos e Solucoes para a Industria e a Saude Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000026420</manufacturerSrn>
    <authorisedRepresentativeName>Rápido e Contínuo Unipessoal LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000039288</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G030601</emdnCode>
    <emdnDescription>INTRAGASTRIC BALLOON SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>94601</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:13:57.738Z</lastUpdated>
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