<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08435389807742</udiDi>
    <basicUdiDi>84353898PLASMATII69</basicUdiDi>
    <tradeName>08435389807742</tradeName>
    <deviceName>HEATING BLOCK</deviceName>
    <manufacturerName>B.T.I. BIOTECHNOLOGY INSTITUTE, S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000001701</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12019099</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PLASMATERM I</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:18:51.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058481670016</udiDi>
    <basicUdiDi>805848167N4SA2.0HS</basicUdiDi>
    <tradeName>RIGENERA MACHINE</tradeName>
    <deviceName>Rigenera machine</deviceName>
    <manufacturerName>HUMAN BRAIN WAVE SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000010074</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12019099</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N4SA</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:09:36.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059441001119</udiDi>
    <basicUdiDi>5060693520020VD</basicUdiDi>
    <tradeName>Nimbus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ArjoHuntleigh AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>649014SK</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:17:08.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059441130765</udiDi>
    <basicUdiDi>5060693520020VD</basicUdiDi>
    <tradeName>Auralis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ArjoHuntleigh AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>636002GR</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:17:04.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059441130772</udiDi>
    <basicUdiDi>5060693520020VD</basicUdiDi>
    <tradeName>Auralis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ArjoHuntleigh AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>636002HR</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:17:04.775Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059441130789</udiDi>
    <basicUdiDi>5060693520020VD</basicUdiDi>
    <tradeName>Auralis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ArjoHuntleigh AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>636002HU</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:17:04.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059441130796</udiDi>
    <basicUdiDi>5060693520020VD</basicUdiDi>
    <tradeName>Auralis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ArjoHuntleigh AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>636002IS</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:17:04.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059441130802</udiDi>
    <basicUdiDi>5060693520020VD</basicUdiDi>
    <tradeName>Auralis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ArjoHuntleigh AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>636002LV</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:17:04.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059441130826</udiDi>
    <basicUdiDi>5060693520020VD</basicUdiDi>
    <tradeName>Auralis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ArjoHuntleigh AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>636002RO</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:17:04.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059441130840</udiDi>
    <basicUdiDi>5060693520020VD</basicUdiDi>
    <tradeName>Auralis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ArjoHuntleigh AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>636002SL</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:17:04.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059441133858</udiDi>
    <basicUdiDi>5060693520020VD</basicUdiDi>
    <tradeName>Auralis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ArjoHuntleigh AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>636002TR</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:17:04.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059441134626</udiDi>
    <basicUdiDi>5060693520020VD</basicUdiDi>
    <tradeName>Auralis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ArjoHuntleigh AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>636002SK</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:17:03.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059441134756</udiDi>
    <basicUdiDi>5060693520020VD</basicUdiDi>
    <tradeName>Auralis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ArjoHuntleigh AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>636002PT</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:17:03.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059441135005</udiDi>
    <basicUdiDi>5060693520020VD</basicUdiDi>
    <tradeName>Alpha Active 3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ArjoHuntleigh AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>648305CS</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:17:03.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059441139621</udiDi>
    <basicUdiDi>5060693520020VD</basicUdiDi>
    <tradeName>Alpha Active 3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ArjoHuntleigh AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>648304AT</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:17:02.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059441139638</udiDi>
    <basicUdiDi>5060693520020VD</basicUdiDi>
    <tradeName>Alpha Active 4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ArjoHuntleigh AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>648314AT</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:17:02.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059441139669</udiDi>
    <basicUdiDi>5060693520020VD</basicUdiDi>
    <tradeName>Nimbus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ArjoHuntleigh AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>649AUT</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:17:02.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059441139676</udiDi>
    <basicUdiDi>5060693520020VD</basicUdiDi>
    <tradeName>Nimbus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ArjoHuntleigh AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>649012AT</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:17:02.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059441141808</udiDi>
    <basicUdiDi>5060693520020VD</basicUdiDi>
    <tradeName>Auralis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ArjoHuntleigh AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>636018</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:17:02.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059441143161</udiDi>
    <basicUdiDi>5060693520020VD</basicUdiDi>
    <tradeName>Alpha Active 5</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ArjoHuntleigh AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>648205BE</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:17:02.059Z</lastUpdated>
  </row>
</eudamedExport>