<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07290019239024</udiDi>
    <basicUdiDi>0729001923CON29</basicUdiDi>
    <tradeName>Console Assembly gen2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FIZE Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000046483</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-FG00-KU00-0005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-12T19:47:45.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290019239031</udiDi>
    <basicUdiDi>0729001923CON29</basicUdiDi>
    <tradeName>Console assembly 5G gen2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FIZE Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000046483</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-FG00-KU00-0006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-12T19:47:32.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>17290019239045</udiDi>
    <basicUdiDi>0729001923CON29</basicUdiDi>
    <tradeName>FIZE kUO console 2.4G with power box EU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FIZE Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000046483</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FKUO2.4G_PB_EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-12T19:47:20.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>27290019239042</udiDi>
    <basicUdiDi>0729001923CON29</basicUdiDi>
    <tradeName>FIZE kUO console 2.4G with power supply EU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FIZE Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000046483</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FKUO2.4G_PS_EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-12T19:46:58.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>17290019239083</udiDi>
    <basicUdiDi>0729001923CON29</basicUdiDi>
    <tradeName>FIZE kUO console 5G with power box EU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FIZE Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000046483</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FKUO5.0G_PB_EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-12T19:46:53.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>27290019239080</udiDi>
    <basicUdiDi>0729001923CON29</basicUdiDi>
    <tradeName>FIZE kUO console 5G with power supply EU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FIZE Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000046483</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FKUO5.0G_PS_EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-12T19:46:38.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290019239215</udiDi>
    <basicUdiDi>0729001923KIT3B</basicUdiDi>
    <tradeName>Disposable Adult Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FIZE Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000046483</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-KT00-KU01-0007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-12T19:46:02.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>17290019239212</udiDi>
    <basicUdiDi>0729001923KIT3B</basicUdiDi>
    <tradeName>FIZE Disposable, Adults, 10EA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FIZE Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000046483</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-FG00-KU03-0003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-12T19:45:42.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290019239208</udiDi>
    <basicUdiDi>0729001923KIT3B</basicUdiDi>
    <tradeName>Disposable Pediatric Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FIZE Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000046483</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-KT00-KU01-0008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-12T19:45:27.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>17290019239205</udiDi>
    <basicUdiDi>0729001923KIT3B</basicUdiDi>
    <tradeName>FIZE Disposable- Pediatrics, 10EA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FIZE Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000046483</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-FG00-KU03-0004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-12T19:45:20.792Z</lastUpdated>
  </row>
</eudamedExport>