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    <udiDi>04562382432160</udiDi>
    <basicUdiDi>456238243MPUK</basicUdiDi>
    <tradeName>Tokai Microcatheter, Carnelian Support BTA</tradeName>
    <deviceName>Tokai Microcatheter</deviceName>
    <manufacturerName>Tokai Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000011106</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRAVASCULAR CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCPB150-E</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:54:41.936Z</lastUpdated>
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  <row>
    <udiDi>04562382431866</udiDi>
    <basicUdiDi>456238243MCTR</basicUdiDi>
    <tradeName>Tokai Microcatheter, Carnelian 2.2</tradeName>
    <deviceName>Tokai Microcatheter</deviceName>
    <manufacturerName>Tokai Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000011106</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PERIPHERAL EMBOLISATION CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCV110S-E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:54:41.136Z</lastUpdated>
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  <row>
    <udiDi>04562382431842</udiDi>
    <basicUdiDi>B-04562382431842</basicUdiDi>
    <tradeName>Tokai Microcatheter, Carnelian 2.2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tokai Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000011106</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCV070-E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:31.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>04562382431859</udiDi>
    <basicUdiDi>B-04562382431859</basicUdiDi>
    <tradeName>Tokai Microcatheter, Carnelian 2.2 [EN]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tokai Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000011106</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PERIPHERAL EMBOLISATION CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCV110-E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:31.787Z</lastUpdated>
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  <row>
    <udiDi>04562382431873</udiDi>
    <basicUdiDi>456238243MCTR</basicUdiDi>
    <tradeName>Tokai Microcatheter, Carnelian 2.2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tokai Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000011106</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCV110M-E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:31.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>04562382431880</udiDi>
    <basicUdiDi>456238243MCTR</basicUdiDi>
    <tradeName>Tokai Microcatheter, Carnelian 2.2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tokai Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000011106</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCV110Q-E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:31.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>04562382431897</udiDi>
    <basicUdiDi>B-04562382431897</basicUdiDi>
    <tradeName>Tokai Microcatheter, Carnelian 2.2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tokai Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000011106</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PERIPHERAL EMBOLISATION CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCV130-E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:31.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>04562382431903</udiDi>
    <basicUdiDi>456238243MCTR</basicUdiDi>
    <tradeName>Tokai Microcatheter, Carnelian 2.2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tokai Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000011106</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRAVASCULAR CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCV135-E</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:31.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>04562382431910</udiDi>
    <basicUdiDi>456238243MCTR</basicUdiDi>
    <tradeName>Tokai Microcatheter, Carnelian 2.2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tokai Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000011106</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRAVASCULAR CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCV135S-E</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:31.599Z</lastUpdated>
  </row>
  <row>
    <udiDi>04562382431927</udiDi>
    <basicUdiDi>456238243MCTR</basicUdiDi>
    <tradeName>Tokai Microcatheter, Carnelian 2.2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tokai Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000011106</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRAVASCULAR CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCV135M-E</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:31.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>04562382431934</udiDi>
    <basicUdiDi>456238243MCTR</basicUdiDi>
    <tradeName>Tokai Microcatheter, Carnelian 2.2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tokai Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000011106</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRAVASCULAR CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCV135Q-E</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:31.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>04562382431941</udiDi>
    <basicUdiDi>456238243MCTR</basicUdiDi>
    <tradeName>Tokai Microcatheter, Carnelian 2.2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tokai Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000011106</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRAVASCULAR CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCV150-E</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:31.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>04562382431958</udiDi>
    <basicUdiDi>456238243MCTR</basicUdiDi>
    <tradeName>Tokai Microcatheter, Carnelian 2.2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tokai Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000011106</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRAVASCULAR CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCV150M-E</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:31.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>04562382431965</udiDi>
    <basicUdiDi>456238243MCTR</basicUdiDi>
    <tradeName>Tokai Microcatheter, Carnelian 2.7</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tokai Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000011106</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRAVASCULAR CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCH105-E</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:31.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>04562382431972</udiDi>
    <basicUdiDi>456238243MCTR</basicUdiDi>
    <tradeName>Tokai Microcatheter, Carnelian 2.7</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tokai Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000011106</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRAVASCULAR CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCH125-E</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:31.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>04562382431989</udiDi>
    <basicUdiDi>456238243MCTR</basicUdiDi>
    <tradeName>Tokai Microcatheter, Carnelian 1.8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tokai Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000011106</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRAVASCULAR CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSV110-E</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:31.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>04562382431996</udiDi>
    <basicUdiDi>456238243MCTR</basicUdiDi>
    <tradeName>Tokai Microcatheter, Carnelian 1.8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tokai Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000011106</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRAVASCULAR CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSV110S-E</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:31.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>04562382432009</udiDi>
    <basicUdiDi>456238243MCTR</basicUdiDi>
    <tradeName>Tokai Microcatheter, Carnelian 1.8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tokai Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000011106</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRAVASCULAR CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSV110M-E</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:31.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>04562382432016</udiDi>
    <basicUdiDi>456238243MCTR</basicUdiDi>
    <tradeName>Tokai Microcatheter, Carnelian 1.8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tokai Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000011106</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRAVASCULAR CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSV110Q-E</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:31.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>04562382432023</udiDi>
    <basicUdiDi>456238243MCTR</basicUdiDi>
    <tradeName>Tokai Microcatheter, Carnelian 1.8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tokai Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000011106</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSV135-E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:31.127Z</lastUpdated>
  </row>
</eudamedExport>