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    <tradeName>00813502012231</tradeName>
    <deviceName>Axillary Insertion Graft Lock</deviceName>
    <manufacturerName>Abiomed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016855</manufacturerSrn>
    <authorisedRepresentativeName>Abiomed Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005280</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C9080</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0052-3008-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:48:41.992Z</lastUpdated>
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    <udiDi>00813502012118</udiDi>
    <basicUdiDi>B-00813502012118</basicUdiDi>
    <tradeName>Impella 5.0</tradeName>
    <deviceName>Impella 5.0</deviceName>
    <manufacturerName>Abiomed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016855</manufacturerSrn>
    <authorisedRepresentativeName>Abiomed Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005280</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C99</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0046-3114</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:48:41.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813502012101</udiDi>
    <basicUdiDi>B-00813502012101</basicUdiDi>
    <tradeName>00813502012101</tradeName>
    <deviceName>Incision Template</deviceName>
    <manufacturerName>Abiomed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016855</manufacturerSrn>
    <authorisedRepresentativeName>Abiomed Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005280</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <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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  <row>
    <udiDi>00813502012088</udiDi>
    <basicUdiDi>B-00813502012088</basicUdiDi>
    <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>
    <riskClass>Sınıf IIa</riskClass>
    <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>
  </row>
  <row>
    <udiDi>00813502012071</udiDi>
    <basicUdiDi>B-00813502012071</basicUdiDi>
    <tradeName>Impella 5.5 with SmartAssist</tradeName>
    <deviceName>Impella 5.5</deviceName>
    <manufacturerName>Abiomed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016855</manufacturerSrn>
    <authorisedRepresentativeName>Abiomed Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005280</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C99</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0550-0007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:48:34.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813502012033</udiDi>
    <basicUdiDi>B-00813502012033</basicUdiDi>
    <tradeName>Impella RP</tradeName>
    <deviceName>Impella RP</deviceName>
    <manufacturerName>Abiomed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016855</manufacturerSrn>
    <authorisedRepresentativeName>Abiomed Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005280</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C99</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0046-3107</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:48:34.063Z</lastUpdated>
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  <row>
    <udiDi>00813502011999</udiDi>
    <basicUdiDi>B-00813502011999</basicUdiDi>
    <tradeName>00813502011999</tradeName>
    <deviceName>Impella Purge Cassette</deviceName>
    <manufacturerName>Abiomed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016855</manufacturerSrn>
    <authorisedRepresentativeName>Abiomed Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005280</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C9080</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0043-0002, 0043-0003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:48:32.349Z</lastUpdated>
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  <row>
    <udiDi>00813502011685</udiDi>
    <basicUdiDi>B-00813502011685</basicUdiDi>
    <tradeName>00813502011685</tradeName>
    <deviceName>Impella CP Introducer Kit</deviceName>
    <manufacturerName>Abiomed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016855</manufacturerSrn>
    <authorisedRepresentativeName>Abiomed Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005280</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0052-3052/0052-0038, 0052-3053/0052-0039</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:48:31.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813502010961</udiDi>
    <basicUdiDi>B-00813502010961</basicUdiDi>
    <tradeName>00813502010961</tradeName>
    <deviceName>Automated Impella Controller</deviceName>
    <manufacturerName>Abiomed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016855</manufacturerSrn>
    <authorisedRepresentativeName>Abiomed Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005280</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12059099</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY -OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0042-0010-EU, 0042-0040-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:48:27.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260113630259</udiDi>
    <basicUdiDi>B-04260113630259</basicUdiDi>
    <tradeName>04260113630259</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abiomed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016855</manufacturerSrn>
    <authorisedRepresentativeName>Abiomed Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005280</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0042-0002, 0042-0012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T15:15:14.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260113630303</udiDi>
    <basicUdiDi>B-04260113630303</basicUdiDi>
    <tradeName>04260113630303</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abiomed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016855</manufacturerSrn>
    <authorisedRepresentativeName>Abiomed Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005280</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0052-3005/0052-3018</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T15:15:14.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813502012002</udiDi>
    <basicUdiDi>081350201199200201QZ</basicUdiDi>
    <tradeName>Impella Purge Cassette</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abiomed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016855</manufacturerSrn>
    <authorisedRepresentativeName>Abiomed Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005280</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONTROLLERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0043-0009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:11.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813502012507</udiDi>
    <basicUdiDi>081350201199200201QZ</basicUdiDi>
    <tradeName>Impella Purge Cassette</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abiomed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016855</manufacturerSrn>
    <authorisedRepresentativeName>Abiomed Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005280</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONTROLLERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000171</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:11.069Z</lastUpdated>
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