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    <tradeName>10841716100397</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>2026-06-02T23:45:56.728Z</lastUpdated>
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    <udiDi>10841716100441</udiDi>
    <basicUdiDi>08417161000006FX</basicUdiDi>
    <tradeName>10841716100441</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>2026-06-02T23:45:56.699Z</lastUpdated>
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    <udiDi>10841716100489</udiDi>
    <basicUdiDi>08417161000006FX</basicUdiDi>
    <tradeName>10841716100489</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>2026-06-02T23:45:56.681Z</lastUpdated>
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    <udiDi>10841716102070</udiDi>
    <basicUdiDi>08417161000006FX</basicUdiDi>
    <tradeName>10841716102070</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>2026-06-02T23:45:56.642Z</lastUpdated>
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    <udiDi>10841716102643</udiDi>
    <basicUdiDi>08417161000009G5</basicUdiDi>
    <tradeName>10841716102643</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>2026-06-02T23:45:56.630Z</lastUpdated>
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    <udiDi>10841716103398</udiDi>
    <basicUdiDi>08417161000015FY</basicUdiDi>
    <tradeName>NEXO</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>2026-06-02T23:45:56.593Z</lastUpdated>
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    <udiDi>10841716104036</udiDi>
    <basicUdiDi>08417161000013FU</basicUdiDi>
    <tradeName>VeraPro AMT</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>2026-05-30T13:39:22.500Z</lastUpdated>
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    <udiDi>10841716104005</udiDi>
    <basicUdiDi>08417161000013FU</basicUdiDi>
    <tradeName>VeraPro S100 Syringe</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>2026-05-29T06:59:52.498Z</lastUpdated>
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    <udiDi>10841716104012</udiDi>
    <basicUdiDi>08417161000013FU</basicUdiDi>
    <tradeName>VeraPro S100 LV Syringe</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>2026-05-29T06:59:52.478Z</lastUpdated>
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    <udiDi>07649996041081</udiDi>
    <basicUdiDi>7649996041VueBoxRF</basicUdiDi>
    <tradeName>Trial GI-Perfusion &amp; Liver DVP version 8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BRACCO SUISSE SA</manufacturerName>
    <manufacturerSrn>CH-MF-000022733</manufacturerSrn>
    <authorisedRepresentativeName>ACIST Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002151</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V92</emdnCode>
    <emdnDescription>MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T05:39:35.856Z</lastUpdated>
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    <udiDi>10841716100595</udiDi>
    <basicUdiDi>08417161000006FX</basicUdiDi>
    <tradeName>RXi Cart</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>2026-05-27T02:36:19.229Z</lastUpdated>
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  <row>
    <udiDi>10841716103084</udiDi>
    <basicUdiDi>08417161000014FW</basicUdiDi>
    <tradeName>ACIST Pro</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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T02:36:19.187Z</lastUpdated>
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  <row>
    <udiDi>10841716103152</udiDi>
    <basicUdiDi>08417161000002FP</basicUdiDi>
    <tradeName>ACIST CVi A2000</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>2026-05-27T02:36:19.153Z</lastUpdated>
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    <udiDi>10841716103169</udiDi>
    <basicUdiDi>08417161000002FP</basicUdiDi>
    <tradeName>ACIST CVi A2000V SYRINGE 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>2026-05-27T02:36:19.124Z</lastUpdated>
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  <row>
    <udiDi>10841716103664</udiDi>
    <basicUdiDi>08417161000014FW</basicUdiDi>
    <tradeName>ACIST Pro</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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T02:36:19.058Z</lastUpdated>
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    <udiDi>10841716103671</udiDi>
    <basicUdiDi>08417161000014FW</basicUdiDi>
    <tradeName>ACIST Pro</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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T02:36:19.035Z</lastUpdated>
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    <udiDi>10841716103800</udiDi>
    <basicUdiDi>08417161000013FU</basicUdiDi>
    <tradeName>VeraPro AngioTouch HiFi 165</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>2026-05-27T02:36:19.008Z</lastUpdated>
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    <udiDi>10841716103817</udiDi>
    <basicUdiDi>08417161000013FU</basicUdiDi>
    <tradeName>VeraPro AngioTouch FLX 165</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>2026-05-27T02:36:18.985Z</lastUpdated>
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    <udiDi>10841716103954</udiDi>
    <basicUdiDi>08417161000012FS</basicUdiDi>
    <tradeName>CT Exprés Multi Patient Set</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>2026-05-27T02:36:18.928Z</lastUpdated>
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    <basicUdiDi>08417161000012FS</basicUdiDi>
    <tradeName>CT Expres Patient Line</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>2026-05-27T02:36:18.898Z</lastUpdated>
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