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    <tradeName>ACIST CVi AngioTouch® AT P54 HAND CONTROLLER KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACIST Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010784</manufacturerSrn>
    <authorisedRepresentativeName>ACIST Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002151</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T22:35:50.162Z</lastUpdated>
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    <basicUdiDi>08417161000002FP</basicUdiDi>
    <tradeName>ACIST CVi AngioTouch® AT P65 HAND CONTROLLER KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACIST Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010784</manufacturerSrn>
    <authorisedRepresentativeName>ACIST Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002151</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
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    <basicUdiDi>08417161000002FP</basicUdiDi>
    <tradeName>ACIST CVi AngioTouch® AT X65 HAND CONTROLLER KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACIST Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010784</manufacturerSrn>
    <authorisedRepresentativeName>ACIST Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002151</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
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    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>10841716103572</udiDi>
    <basicUdiDi>B-10841716103572</basicUdiDi>
    <tradeName>RXi System dPR</tradeName>
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    <manufacturerName>ACIST Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010784</manufacturerSrn>
    <authorisedRepresentativeName>ACIST Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002151</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T22:35:50.104Z</lastUpdated>
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    <udiDi>10841716100403</udiDi>
    <basicUdiDi>08417161000006FX</basicUdiDi>
    <tradeName>RXi Pa Cable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACIST Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010784</manufacturerSrn>
    <authorisedRepresentativeName>ACIST Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002151</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T02:27:06.630Z</lastUpdated>
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    <udiDi>10841716100410</udiDi>
    <basicUdiDi>08417161000006FX</basicUdiDi>
    <tradeName>RXi Pa Cable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACIST Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010784</manufacturerSrn>
    <authorisedRepresentativeName>ACIST Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002151</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T02:27:06.622Z</lastUpdated>
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    <udiDi>10841716100427</udiDi>
    <basicUdiDi>08417161000006FX</basicUdiDi>
    <tradeName>RXi Pa Cable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACIST Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010784</manufacturerSrn>
    <authorisedRepresentativeName>ACIST Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002151</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T02:27:06.613Z</lastUpdated>
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    <basicUdiDi>08417161000006FX</basicUdiDi>
    <tradeName>RXi Pd Cable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACIST Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010784</manufacturerSrn>
    <authorisedRepresentativeName>ACIST Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002151</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T02:27:06.604Z</lastUpdated>
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    <basicUdiDi>08417161000006FX</basicUdiDi>
    <tradeName>RXi Pa Cable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACIST Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010784</manufacturerSrn>
    <authorisedRepresentativeName>ACIST Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002151</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T02:27:06.595Z</lastUpdated>
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    <basicUdiDi>08417161000006FX</basicUdiDi>
    <tradeName>RXi Pa Cable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACIST Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010784</manufacturerSrn>
    <authorisedRepresentativeName>ACIST Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002151</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T02:27:06.584Z</lastUpdated>
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    <udiDi>10841716100571</udiDi>
    <basicUdiDi>08417161000006FX</basicUdiDi>
    <tradeName>RXi Pa Cable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACIST Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010784</manufacturerSrn>
    <authorisedRepresentativeName>ACIST Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002151</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T02:27:06.576Z</lastUpdated>
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    <udiDi>10841716100588</udiDi>
    <basicUdiDi>08417161000006FX</basicUdiDi>
    <tradeName>RXi Bed Rail Mount</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACIST Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010784</manufacturerSrn>
    <authorisedRepresentativeName>ACIST Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002151</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T02:27:06.568Z</lastUpdated>
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    <udiDi>10841716102018</udiDi>
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    <tradeName>RXi Pd Cable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACIST Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010784</manufacturerSrn>
    <authorisedRepresentativeName>ACIST Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002151</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T02:27:06.560Z</lastUpdated>
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    <udiDi>10841716102636</udiDi>
    <basicUdiDi>08417161000009G5</basicUdiDi>
    <tradeName>HDi Bed Mount</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACIST Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010784</manufacturerSrn>
    <authorisedRepresentativeName>ACIST Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002151</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T02:27:06.552Z</lastUpdated>
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    <udiDi>10841716102841</udiDi>
    <basicUdiDi>08417161000006FX</basicUdiDi>
    <tradeName>RXi Pd Cable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACIST Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010784</manufacturerSrn>
    <authorisedRepresentativeName>ACIST Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002151</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T02:27:06.544Z</lastUpdated>
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    <udiDi>10841716103145</udiDi>
    <basicUdiDi>08417161000006FX</basicUdiDi>
    <tradeName>RXi Pa Cable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACIST Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010784</manufacturerSrn>
    <authorisedRepresentativeName>ACIST Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002151</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T02:27:06.534Z</lastUpdated>
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    <udiDi>10841716103176</udiDi>
    <basicUdiDi>08417161000002FP</basicUdiDi>
    <tradeName>ACIST CVi BT2000 MANIFOLD KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACIST Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010784</manufacturerSrn>
    <authorisedRepresentativeName>ACIST Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002151</authorisedRepresentativeSrn>
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    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T02:27:06.524Z</lastUpdated>
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    <udiDi>10841716104043</udiDi>
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    <tradeName>HubVue Imaging Workflow System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACIST Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010784</manufacturerSrn>
    <authorisedRepresentativeName>ACIST Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002151</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T02:27:06.512Z</lastUpdated>
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