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<eudamedExport entity="devices">
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    <udiDi>04545428038366</udiDi>
    <basicUdiDi>B-04545428038366</basicUdiDi>
    <tradeName>RevoWave PX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PIOLAX MEDICAL DEVICES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000007059</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRICHOTOMY MANUAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RWHJ-3545SJ</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:13.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>04545428038373</udiDi>
    <basicUdiDi>B-04545428038373</basicUdiDi>
    <tradeName>RevoWave PX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PIOLAX MEDICAL DEVICES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000007059</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRICHOTOMY MANUAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RWHJ-2545SJ</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:13.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>04545428038380</udiDi>
    <basicUdiDi>B-04545428038380</basicUdiDi>
    <tradeName>RevoWave PX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PIOLAX MEDICAL DEVICES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000007059</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRICHOTOMY MANUAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RWUA-2545F2A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:13.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>04545428038397</udiDi>
    <basicUdiDi>B-04545428038397</basicUdiDi>
    <tradeName>RevoWave PX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PIOLAX MEDICAL DEVICES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000007059</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRICHOTOMY MANUAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RWUA-2545F5A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:13.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>04545428038403</udiDi>
    <basicUdiDi>B-04545428038403</basicUdiDi>
    <tradeName>RevoWave PX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PIOLAX MEDICAL DEVICES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000007059</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRICHOTOMY MANUAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RWUS-2545S5A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:13.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>04545428038984</udiDi>
    <basicUdiDi>B-04545428038984</basicUdiDi>
    <tradeName>RevoWave PX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PIOLAX MEDICAL DEVICES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000007059</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ERCP AND SPHINCTEROTOMY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RWSS-3545I</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:13.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>04545428038991</udiDi>
    <basicUdiDi>B-04545428038991</basicUdiDi>
    <tradeName>RevoWave PX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PIOLAX MEDICAL DEVICES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000007059</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ERCP AND SPHINCTEROTOMY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RWSA-3545I</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:13.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>04545428039004</udiDi>
    <basicUdiDi>B-04545428039004</basicUdiDi>
    <tradeName>RevoWave PX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PIOLAX MEDICAL DEVICES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000007059</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRICHOTOMY MANUAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RWHS-3545I</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:13.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>04545428039011</udiDi>
    <basicUdiDi>B-04545428039011</basicUdiDi>
    <tradeName>RevoWave PX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PIOLAX MEDICAL DEVICES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000007059</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRICHOTOMY MANUAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RWHA-3545I</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:13.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>04545428039028</udiDi>
    <basicUdiDi>B-04545428039028</basicUdiDi>
    <tradeName>RevoWave PX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PIOLAX MEDICAL DEVICES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000007059</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRICHOTOMY MANUAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RWUA-3545P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:13.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>04545428039035</udiDi>
    <basicUdiDi>B-04545428039035</basicUdiDi>
    <tradeName>RevoWave PX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PIOLAX MEDICAL DEVICES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000007059</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRICHOTOMY MANUAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RWSS-3526I</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:13.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>04545428039042</udiDi>
    <basicUdiDi>B-04545428039042</basicUdiDi>
    <tradeName>RevoWave PX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PIOLAX MEDICAL DEVICES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000007059</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRICHOTOMY MANUAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RWSA-3526I</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:13.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>04545428039059</udiDi>
    <basicUdiDi>B-04545428039059</basicUdiDi>
    <tradeName>RevoWave PX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PIOLAX MEDICAL DEVICES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000007059</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRICHOTOMY MANUAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RWSA-3555I</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:13.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>04545428039066</udiDi>
    <basicUdiDi>B-04545428039066</basicUdiDi>
    <tradeName>RevoWave PX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PIOLAX MEDICAL DEVICES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000007059</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRICHOTOMY MANUAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RWUA-2555I</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:13.109Z</lastUpdated>
  </row>
  <row>
    <udiDi>04545428039073</udiDi>
    <basicUdiDi>B-04545428039073</basicUdiDi>
    <tradeName>RevoWave PX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PIOLAX MEDICAL DEVICES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000007059</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRICHOTOMY MANUAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RWHS-2545I</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:13.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>04545428039080</udiDi>
    <basicUdiDi>B-04545428039080</basicUdiDi>
    <tradeName>RevoWave PX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PIOLAX MEDICAL DEVICES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000007059</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRICHOTOMY MANUAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RWHA-2545I</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:13.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>04545428039097</udiDi>
    <basicUdiDi>B-04545428039097</basicUdiDi>
    <tradeName>RevoWave PX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PIOLAX MEDICAL DEVICES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000007059</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRICHOTOMY MANUAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RWSS-3555I</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:13.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>04545428039103</udiDi>
    <basicUdiDi>B-04545428039103</basicUdiDi>
    <tradeName>RevoWave PX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PIOLAX MEDICAL DEVICES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000007059</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRICHOTOMY MANUAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RWUS-2555I</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:13.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>04545428039110</udiDi>
    <basicUdiDi>B-04545428039110</basicUdiDi>
    <tradeName>RevoWave PX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PIOLAX MEDICAL DEVICES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000007059</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRICHOTOMY MANUAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RWHS-3526ID</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:13.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>04545428039127</udiDi>
    <basicUdiDi>B-04545428039127</basicUdiDi>
    <tradeName>RevoWave PX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PIOLAX MEDICAL DEVICES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000007059</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRICHOTOMY MANUAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RWHA-3526ID</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:13.002Z</lastUpdated>
  </row>
</eudamedExport>