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    <tradeName>Disposable-Set of Water-Heater-Cooler HC3</tradeName>
    <deviceName>Disposable-Set of Water-Heater-Cooler HC3</deviceName>
    <manufacturerName>Weirich Medical Equipment (Tianjin) Co.Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039461</manufacturerSrn>
    <authorisedRepresentativeName>WEIRICH Medizintechnik GmbH</authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>WEI-HC3-DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:38:47.834Z</lastUpdated>
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    <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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    <deviceStatus>Piyasada</deviceStatus>
    <reference>017682</reference>
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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>
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    <legislation>UNKNOWN</legislation>
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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>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>018060</reference>
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    <lastUpdated>2026-07-16T05:16:58.931Z</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>C9080</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>018105</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:16:58.912Z</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>C9080</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>018174</reference>
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    <lastUpdated>2026-07-16T05:16:58.891Z</lastUpdated>
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    <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>
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    <emdnDescription>CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>017753</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <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>C9080</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>018111</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:16:58.852Z</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>C9080</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>016217</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:16:58.825Z</lastUpdated>
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    <udiDi>10841716102070</udiDi>
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    <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>C9080</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>018059</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:16:58.804Z</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>C9080</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>018726</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:16:58.718Z</lastUpdated>
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    <udiDi>10841716103145</udiDi>
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    <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>C9080</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>019427</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:16:58.691Z</lastUpdated>
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    <udiDi>10841716100397</udiDi>
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    <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>MDR 2017/745</legislation>
    <emdnCode>C9080</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>017755</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:16:42.097Z</lastUpdated>
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    <basicUdiDi>063478208300897FR</basicUdiDi>
    <tradeName>00634782045180</tradeName>
    <deviceName>Blood Pressure Cuff</deviceName>
    <manufacturerName>American Diagnostic Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000021544</manufacturerSrn>
    <authorisedRepresentativeName>S.C. Cattus S.R.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>RO-AR-000020096</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C9080</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8974-10</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:06:51.980Z</lastUpdated>
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    <tradeName>08714729896838</tradeName>
    <deviceName>Permanent Sled</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>C9080</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>H749393160100</reference>
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    <lastUpdated>2026-07-15T20:09:35.868Z</lastUpdated>
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    <tradeName>08714729228684</tradeName>
    <deviceName>Disposable Pullback Sled</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>H749A70200</reference>
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    <lastUpdated>2026-07-15T20:08:19.687Z</lastUpdated>
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    <tradeName>06971162816997</tradeName>
    <deviceName>Guidewire Syringe</deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>C9080</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>251001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:17:48.335Z</lastUpdated>
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    <udiDi>00813502012231</udiDi>
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    <tradeName>00813502012231</tradeName>
    <deviceName>Axillary Insertion Graft Lock</deviceName>
    <manufacturerName>Abiomed Inc.</manufacturerName>
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    <authorisedRepresentativeName>Abiomed Europe GmbH</authorisedRepresentativeName>
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    <emdnCode>C9080</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>0052-3008-EU</reference>
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    <lastUpdated>2026-07-04T17:48:41.992Z</lastUpdated>
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    <deviceName>Incision Template</deviceName>
    <manufacturerName>Abiomed Inc.</manufacturerName>
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    <authorisedRepresentativeSrn>DE-AR-000005280</authorisedRepresentativeSrn>
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    <emdnCode>C9080</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0550-3020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:48:39.938Z</lastUpdated>
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    <tradeName>00813502012088</tradeName>
    <deviceName>Silicone Plugs</deviceName>
    <manufacturerName>Abiomed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016855</manufacturerSrn>
    <authorisedRepresentativeName>Abiomed Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005280</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>C9080</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0046-3028</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:48:38.877Z</lastUpdated>
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