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    <tradeName>ACIST Pro Hemodynamic 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>019336</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T04:08:11.992Z</lastUpdated>
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    <udiDi>10841716103022</udiDi>
    <basicUdiDi>08417161000016G2</basicUdiDi>
    <tradeName>ACIST Pro Hemodynamic 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>019337</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T04:08:03.447Z</lastUpdated>
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    <udiDi>10841716103039</udiDi>
    <basicUdiDi>08417161000016G2</basicUdiDi>
    <tradeName>ACIST Pro Hemodynamic 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>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T04:08:03.326Z</lastUpdated>
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    <udiDi>10841716103411</udiDi>
    <basicUdiDi>08417161000016G2</basicUdiDi>
    <tradeName>ACIST Pro Single Transducer 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>019608</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T04:08:03.167Z</lastUpdated>
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    <udiDi>10841716103428</udiDi>
    <basicUdiDi>08417161000016G2</basicUdiDi>
    <tradeName>ACIST Pro Triple Transducer 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>019609</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T04:08:03.031Z</lastUpdated>
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    <udiDi>10841716103657</udiDi>
    <basicUdiDi>08417161000016G2</basicUdiDi>
    <tradeName>AngioTouch Module (15')</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>019312</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T04:08:02.679Z</lastUpdated>
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    <udiDi>10841716103008</udiDi>
    <basicUdiDi>08417161000016G2</basicUdiDi>
    <tradeName>ACIST Pro Hemodynamic 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>019335</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:43:02.650Z</lastUpdated>
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    <udiDi>10841716103626</udiDi>
    <basicUdiDi>08417161000016G2</basicUdiDi>
    <tradeName>ACIST Pro 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>019394</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:43:02.426Z</lastUpdated>
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    <udiDi>10841716103909</udiDi>
    <basicUdiDi>08417161000016G2</basicUdiDi>
    <tradeName>ACIST Pro Small 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>019257</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:43:02.321Z</lastUpdated>
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    <udiDi>10841716103916</udiDi>
    <basicUdiDi>08417161000016G2</basicUdiDi>
    <tradeName>ACIST Pro Processing Unit 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>019305</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:43:01.592Z</lastUpdated>
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    <udiDi>30841716100070</udiDi>
    <basicUdiDi>08417161000003FR</basicUdiDi>
    <tradeName>CVi 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>014668</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:57:17.570Z</lastUpdated>
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    <udiDi>10841716102445</udiDi>
    <basicUdiDi>B-10841716102445</basicUdiDi>
    <tradeName>ACIST CVi Contrast Delivery 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>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>014657</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T19:47:07.937Z</lastUpdated>
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    <udiDi>10841716102452</udiDi>
    <basicUdiDi>B-10841716102452</basicUdiDi>
    <tradeName>ACIST CVi Contrast Delivery 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>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>014658</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T19:47:05.334Z</lastUpdated>
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    <udiDi>10841716104296</udiDi>
    <basicUdiDi>08417161000014FW</basicUdiDi>
    <tradeName>ACIST Pro Diagnostic 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>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>019304</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T21:57:30.432Z</lastUpdated>
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    <udiDi>10841716104029</udiDi>
    <basicUdiDi>08417161000012FS</basicUdiDi>
    <tradeName>CT Expres Day 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>801185-005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:05:35.968Z</lastUpdated>
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    <udiDi>10841716104067</udiDi>
    <basicUdiDi>08417161000012FS</basicUdiDi>
    <tradeName>CT Expres 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>801176-003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:05:28.774Z</lastUpdated>
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    <udiDi>10841716103947</udiDi>
    <basicUdiDi>08417161000012FS</basicUdiDi>
    <tradeName>CT Expres Bottle Spike</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>801178-003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:05:23.587Z</lastUpdated>
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    <udiDi>30841716100186</udiDi>
    <basicUdiDi>08417161000003FR</basicUdiDi>
    <tradeName>CVi Adjustable Arm</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>0146CC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:16:49.574Z</lastUpdated>
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    <udiDi>30841716100988</udiDi>
    <basicUdiDi>08417161000003FR</basicUdiDi>
    <tradeName>"	CVi X-Ray Interface Cable (Toshiba) Controller 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>015757</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:16:49.549Z</lastUpdated>
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    <udiDi>30841716101046</udiDi>
    <basicUdiDi>08417161000003FR</basicUdiDi>
    <tradeName>CVi X-Ray Interface Cable (Toshiba)</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>0146CI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:16:49.527Z</lastUpdated>
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