<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00813830022353</udiDi>
    <basicUdiDi>B-00813830022353</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010180</emdnCode>
    <emdnDescription>ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>35000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:49:45.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278125583</udiDi>
    <basicUdiDi>B-00195278125583</basicUdiDi>
    <tradeName>CBS Reusable Absorber Canister</tradeName>
    <deviceName>CBS Reusable Absorber Canister</deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014656</manufacturerSrn>
    <authorisedRepresentativeName>GE Healthcare Finland Oy</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FI-AR-000017101</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010180</emdnCode>
    <emdnDescription>ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2071165-001-S</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:35.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840682135290</udiDi>
    <basicUdiDi>8406821BUG00346HK</basicUdiDi>
    <tradeName>CBS Reusable Absorber Canister</tradeName>
    <deviceName>CBS Reusable Absorber Canister</deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014656</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010180</emdnCode>
    <emdnDescription>ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2071165-001-S</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:56:18.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840682124720</udiDi>
    <basicUdiDi>8406821BUG00339HN</basicUdiDi>
    <tradeName>TEC 820 SEV</tradeName>
    <deviceName>TEC 820 ISO, TEC 820 SEV, TEC 850 ISO, TEC 850 SEV</deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014656</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010180</emdnCode>
    <emdnDescription>ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1177-9820-SEV</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:56:08.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048675697718</udiDi>
    <basicUdiDi>0404867511080536K19Z000T5</basicUdiDi>
    <tradeName>SelfTestLung</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010180</emdnCode>
    <emdnDescription>ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP20020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T22:30:52.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953043851</udiDi>
    <basicUdiDi>08406821BUG004777P</basicUdiDi>
    <tradeName>Serenity T Vaporizer GEHC ISO Easy-Fil EN-US, UK, ZA, AU, IL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014656</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010180</emdnCode>
    <emdnDescription>ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TF11G01NN00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:34:49.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953043868</udiDi>
    <basicUdiDi>08406821BUG004777P</basicUdiDi>
    <tradeName>Serenity T Vaporizer GEHC SEV Quik-Fil EN-US / UK / ZA / AU /IL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014656</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010180</emdnCode>
    <emdnDescription>ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS30G01NN00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:34:49.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953043875</udiDi>
    <basicUdiDi>08406821BUG004777P</basicUdiDi>
    <tradeName>Serenity S Vaporizer BAXTER SEV Safe-T-Seal EN-UK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014656</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010180</emdnCode>
    <emdnDescription>ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS40B01NN07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:34:49.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953043882</udiDi>
    <basicUdiDi>08406821BUG004777P</basicUdiDi>
    <tradeName>Serenity T Vaporizer PIRAMAL DES Fixed-Filler EN-UK, ZA, AU, IL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014656</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010180</emdnCode>
    <emdnDescription>ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD70P01NN00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:34:49.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953043899</udiDi>
    <basicUdiDi>08406821BUG004777P</basicUdiDi>
    <tradeName>Serenity S Vaporizer GEHC DES Fixed-Filler EN-UK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014656</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010180</emdnCode>
    <emdnDescription>ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD70G01NN07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:34:49.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953043905</udiDi>
    <basicUdiDi>08406821BUG004777P</basicUdiDi>
    <tradeName>Serenity S Vaporizer GEHC SEV Quik-Fil EN-UK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014656</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010180</emdnCode>
    <emdnDescription>ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS30G01NN07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:34:49.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953043912</udiDi>
    <basicUdiDi>08406821BUG004777P</basicUdiDi>
    <tradeName>Serenity T Vaporizer GEHC SEV Easy-Fil EN-US, UK, ZA, AU, IL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014656</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010180</emdnCode>
    <emdnDescription>ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS22G01NN00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:34:49.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953043929</udiDi>
    <basicUdiDi>08406821BUG004777P</basicUdiDi>
    <tradeName>Serenity S Vaporizer GEHC SEV Piramal-Fill EN-UK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014656</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010180</emdnCode>
    <emdnDescription>ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS50G01NN07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:34:49.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953043936</udiDi>
    <basicUdiDi>08406821BUG004777P</basicUdiDi>
    <tradeName>Serenity S Vaporizer GEHC ISO Easy-Fil EN-UK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014656</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010180</emdnCode>
    <emdnDescription>ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SF11G01NN07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:34:49.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953043943</udiDi>
    <basicUdiDi>08406821BUG004777P</basicUdiDi>
    <tradeName>Serenity T Vaporizer GEHC SEV Safe-T-Seal EN-US, UK, ZA, AU, IL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014656</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010180</emdnCode>
    <emdnDescription>ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS40G01NN00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:34:49.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953043950</udiDi>
    <basicUdiDi>08406821BUG004777P</basicUdiDi>
    <tradeName>Serenity T Vaporizer PIRAMAL SEV Piramal-Fill EN-US, UK, ZA, AU, IL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014656</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010180</emdnCode>
    <emdnDescription>ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS50P01NN00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:34:49.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953057995</udiDi>
    <basicUdiDi>08406821BUG004777P</basicUdiDi>
    <tradeName>Serenity S Vaporizer GEHC DES Safe-Fil RO, ES, PT, EL, ET CEE 7/7 Power Cord</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014656</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010180</emdnCode>
    <emdnDescription>ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD60G06NN05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:34:49.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953058008</udiDi>
    <basicUdiDi>08406821BUG004777P</basicUdiDi>
    <tradeName>Serenity S Vaporizer GEHC SEV Easy-Fil RO, ES, PT, EL, ET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014656</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010180</emdnCode>
    <emdnDescription>ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS22G06NN05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:34:49.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953102244</udiDi>
    <basicUdiDi>08406821BUG004777P</basicUdiDi>
    <tradeName>Serenity T Vaporizer GEHC SEV Quik-Fil FR, DE, NL, IT, EN</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014656</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010180</emdnCode>
    <emdnDescription>ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS30G02NN00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:34:49.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953102251</udiDi>
    <basicUdiDi>08406821BUG004777P</basicUdiDi>
    <tradeName>Serenity T Vaporizer GEHC DES Safe-Fil EN-US / UK / ZA / AU / IL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014656</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010180</emdnCode>
    <emdnDescription>ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD60G01NN00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:34:49.345Z</lastUpdated>
  </row>
</eudamedExport>