<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05700002192684</udiDi>
    <basicUdiDi>57000021926TOOs-SD02KF</basicUdiDi>
    <tradeName>Acoustic Window ONE-M</tradeName>
    <deviceName>System ONE-M - Film for transparent acoustic window</deviceName>
    <manufacturerName>TOOsonix A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014211</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD02</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:28:59.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700002192677</udiDi>
    <basicUdiDi>57000021926TOOs-SD01KD</basicUdiDi>
    <tradeName>Collar ONE-M</tradeName>
    <deviceName>System ONE-M - Collars for acoustic window fixation</deviceName>
    <manufacturerName>TOOsonix A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014211</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD01</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:28:58.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700002192608</udiDi>
    <basicUdiDi>57000021926SysONE-MRZ</basicUdiDi>
    <tradeName>System ONE-M - Schuko</tradeName>
    <deviceName>System ONE-M</deviceName>
    <manufacturerName>TOOsonix A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014211</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S02</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:28:57.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700002192615</udiDi>
    <basicUdiDi>57000021926SysONE-MRZ</basicUdiDi>
    <tradeName>H03</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOOsonix A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014211</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTIFUNCTIONAL TRANSDUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H03 - 0.8 mm</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:48:48.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700002192622</udiDi>
    <basicUdiDi>57000021926SysONE-MRZ</basicUdiDi>
    <tradeName>H03</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOOsonix A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014211</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTIFUNCTIONAL TRANSDUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H03-1.3 mm</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:48:48.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700002192639</udiDi>
    <basicUdiDi>57000021926SysONE-MRZ</basicUdiDi>
    <tradeName>H03</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOOsonix A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014211</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTIFUNCTIONAL TRANSDUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H03 - 1.8 mm</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:48:48.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700002192646</udiDi>
    <basicUdiDi>57000021926SysONE-MRZ</basicUdiDi>
    <tradeName>H03</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOOsonix A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014211</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTIFUNCTIONAL TRANSDUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H03 - 2.3 mm</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:48:48.170Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700002192653</udiDi>
    <basicUdiDi>57000021926SysONE-MRZ</basicUdiDi>
    <tradeName>System ONE-M - DK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOOsonix A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014211</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S02</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:48:48.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700002192660</udiDi>
    <basicUdiDi>57000021926SysONE-MRZ</basicUdiDi>
    <tradeName>System ONE-M - CH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOOsonix A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014211</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S02</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:48:48.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700002192691</udiDi>
    <basicUdiDi>57000021926SysONE-MRZ</basicUdiDi>
    <tradeName>System ONE-M - UK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOOsonix A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014211</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S02</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:48:48.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700002312709</udiDi>
    <basicUdiDi>57000021926SysONE-MRZ</basicUdiDi>
    <tradeName>System ONE-M - IT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOOsonix A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014211</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S02</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:48:47.477Z</lastUpdated>
  </row>
</eudamedExport>