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    <tradeName>ASTar Instrument</tradeName>
    <deviceName>ASTar Instrument</deviceName>
    <manufacturerName>Q-linea AB</manufacturerName>
    <manufacturerSrn>SE-MF-000013026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010180</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50003135</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:05:14.484Z</lastUpdated>
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    <udiDi>07350136800351</udiDi>
    <basicUdiDi>735013680500053925Y</basicUdiDi>
    <tradeName>ASTar BC G- Kit software CE-IVDR</tradeName>
    <deviceName>ASTar BC G- Kit software CE-IVDR</deviceName>
    <manufacturerName>Q-linea AB</manufacturerName>
    <manufacturerSrn>SE-MF-000013026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50005392</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:48:55.777Z</lastUpdated>
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    <udiDi>07350136800146</udiDi>
    <basicUdiDi>735013680500053925Y</basicUdiDi>
    <tradeName>ASTar BC G- Kit software, (EUCAST)</tradeName>
    <deviceName>ASTar BC G- Kit software CE-IVDR</deviceName>
    <manufacturerName>Q-linea AB</manufacturerName>
    <manufacturerSrn>SE-MF-000013026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50005392</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:48:54.353Z</lastUpdated>
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    <udiDi>07350136800023</udiDi>
    <basicUdiDi>7350136805000617965</basicUdiDi>
    <tradeName>ASTar BC G- Consumable kit</tradeName>
    <deviceName>ASTar BC G- Kit</deviceName>
    <manufacturerName>Q-linea AB</manufacturerName>
    <manufacturerSrn>SE-MF-000013026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50003905</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:48:53.127Z</lastUpdated>
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    <udiDi>07350136800016</udiDi>
    <basicUdiDi>7350136805000617965</basicUdiDi>
    <tradeName>ASTar BC G- Frozen insert</tradeName>
    <deviceName>ASTar BC G- Kit</deviceName>
    <manufacturerName>Q-linea AB</manufacturerName>
    <manufacturerSrn>SE-MF-000013026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50003855</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:48:51.962Z</lastUpdated>
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