<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>07540281000236</udiDi>
    <basicUdiDi>75402810200097</basicUdiDi>
    <tradeName>SONALLEVE MR-HIFU V2 ACHIEVA 1.5T</tradeName>
    <deviceName>Sonalleve MR-HIFU</deviceName>
    <manufacturerName>Profound Medical Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028761</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1204021501</emdnCode>
    <emdnDescription>MULTI-DISTRICT ONCOLOGICAL HYPERTHERMIA EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>451000080766</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:26:51.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540281000014</udiDi>
    <basicUdiDi>B-07540281000014</basicUdiDi>
    <tradeName>TULSA-PRO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Profound Medical Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028761</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TULSA-PRO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:06.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540281000243</udiDi>
    <basicUdiDi>B-07540281000243</basicUdiDi>
    <tradeName>Sonalleve</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Profound Medical Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028761</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTI-DISTRICT ONCOLOGICAL HYPERTHERMIA EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>451000080776</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:06.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540281000250</udiDi>
    <basicUdiDi>B-07540281000250</basicUdiDi>
    <tradeName>Sonalleve</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Profound Medical Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028761</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTI-DISTRICT ONCOLOGICAL HYPERTHERMIA EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>451000080786</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:06.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540281000267</udiDi>
    <basicUdiDi>B-07540281000267</basicUdiDi>
    <tradeName>Sonalleve</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Profound Medical Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028761</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTI-DISTRICT ONCOLOGICAL HYPERTHERMIA EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>451000080796</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:06.692Z</lastUpdated>
  </row>
</eudamedExport>