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    <deviceName>Sonablate HIFU consumables</deviceName>
    <manufacturerName>Focus Surgery, Inc.</manufacturerName>
    <manufacturerSrn>US-PR-000045638</manufacturerSrn>
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    <riskClass>Sınıf I</riskClass>
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    <emdnDescription>PROSTATE THERMOTHERAPY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404-13500-0001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:35:58.676Z</lastUpdated>
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    <tradeName>Water Path Kit</tradeName>
    <deviceName>Sonablate HIFU consumables</deviceName>
    <manufacturerName>Focus Surgery, Inc.</manufacturerName>
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    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
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    <emdnDescription>PROSTATE THERMOTHERAPY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E01017AST61</reference>
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    <lastUpdated>2026-07-15T19:35:55.300Z</lastUpdated>
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    <tradeName>Water Path Kit</tradeName>
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    <manufacturerName>Focus Surgery, Inc.</manufacturerName>
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    <basicUdiDi>00850071153HIFUpackUS</basicUdiDi>
    <tradeName>Sonablate Insertion Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Focus Surgery, Inc.</manufacturerName>
    <manufacturerSrn>US-PR-000045638</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Z12160385</emdnCode>
    <emdnDescription>PROSTATE THERMOTHERAPY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404-14500-0003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:36.438Z</lastUpdated>
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    <udiDi>00850071153101</udiDi>
    <basicUdiDi>00850071153HIFUkitsX2</basicUdiDi>
    <tradeName>O-Ring Applicator Tool</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Focus Surgery, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012164</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12160385</emdnCode>
    <emdnDescription>PROSTATE THERMOTHERAPY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>302-08119-1002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:36.408Z</lastUpdated>
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