<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>09120057172893</udiDi>
    <basicUdiDi>912005717CEB0203QJ</basicUdiDi>
    <tradeName>Jet-Ventilation tubing set, EvoConnect™ to EndoConnect™, single use</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CARL REINER GmbH Medizintechnik für Diagnose und Therapie Manufaktur chirurgischer Instrumente</manufacturerName>
    <manufacturerSrn>AT-MF-000001504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203010501</emdnCode>
    <emdnDescription>HIGH–FREQUENCY PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJVNA113205</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:58:19.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>09120057172978</udiDi>
    <basicUdiDi>912005717CEB0203QJ</basicUdiDi>
    <tradeName>Single Use Jet Tubing Set for 1 LUM Mode with EasyConnect™ System, length 200 cm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CARL REINER GmbH Medizintechnik für Diagnose und Therapie Manufaktur chirurgischer Instrumente</manufacturerName>
    <manufacturerSrn>AT-MF-000001504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203010501</emdnCode>
    <emdnDescription>HIGH–FREQUENCY PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTFS-220-1N1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:58:19.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>09120057172992</udiDi>
    <basicUdiDi>912005717CEB0203QJ</basicUdiDi>
    <tradeName>Single Use Tubing Set complete, for p-BLV™ Module / p-BLV™ Converter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CARL REINER GmbH Medizintechnik für Diagnose und Therapie Manufaktur chirurgischer Instrumente</manufacturerName>
    <manufacturerSrn>AT-MF-000001504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203010501</emdnCode>
    <emdnDescription>HIGH–FREQUENCY PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTFS-220-SN2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:58:19.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904269462236</udiDi>
    <basicUdiDi>B-18904269462236</basicUdiDi>
    <tradeName>SkanRespiro Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SKANRAY TECHNOLOGIES LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000034819</manufacturerSrn>
    <authorisedRepresentativeName>SKANRAY EUROPE SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000013034</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010599</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR HOSPITAL USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3-75-390-0231-83</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:29:47.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904269462229</udiDi>
    <basicUdiDi>B-18904269462229</basicUdiDi>
    <tradeName>SkanRespiro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SKANRAY TECHNOLOGIES LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000034819</manufacturerSrn>
    <authorisedRepresentativeName>SKANRAY EUROPE SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000013034</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010599</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR HOSPITAL USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3-75-390-0230-86</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:29:46.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904269462212</udiDi>
    <basicUdiDi>B-18904269462212</basicUdiDi>
    <tradeName>SkanRespiro Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SKANRAY TECHNOLOGIES LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000034819</manufacturerSrn>
    <authorisedRepresentativeName>SKANRAY EUROPE SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000013034</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010599</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR HOSPITAL USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3-75-390-0227-95</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:28:16.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904269462205</udiDi>
    <basicUdiDi>B-18904269462205</basicUdiDi>
    <tradeName>SkanRespiro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SKANRAY TECHNOLOGIES LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000034819</manufacturerSrn>
    <authorisedRepresentativeName>SKANRAY EUROPE SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000013034</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010599</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR HOSPITAL USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3-75-390-0192-06</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:28:15.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>09420012422354</udiDi>
    <basicUdiDi>B-09420012422354</basicUdiDi>
    <tradeName>F&amp;P AIRVO 2</tradeName>
    <deviceName>AIRVO 2 HUMIDIFIER</deviceName>
    <manufacturerName>Fisher &amp; Paykel Healthcare Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000002556</manufacturerSrn>
    <authorisedRepresentativeName>FISHER &amp; PAYKEL HEALTHCARE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000294</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010504</emdnCode>
    <emdnDescription>ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PT101UK</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:51:15.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>09420012422286</udiDi>
    <basicUdiDi>B-09420012422286</basicUdiDi>
    <tradeName>F&amp;P AIRVO 2</tradeName>
    <deviceName>AIRVO 2 HUMIDIFIER</deviceName>
    <manufacturerName>Fisher &amp; Paykel Healthcare Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000002556</manufacturerSrn>
    <authorisedRepresentativeName>FISHER &amp; PAYKEL HEALTHCARE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000294</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010504</emdnCode>
    <emdnDescription>ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PT101EW</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:51:14.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>09420012422194</udiDi>
    <basicUdiDi>B-09420012422194</basicUdiDi>
    <tradeName>F&amp;P MYAIRVO 2</tradeName>
    <deviceName>myAIRVO 2 HUMIDIFIER</deviceName>
    <manufacturerName>Fisher &amp; Paykel Healthcare Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000002556</manufacturerSrn>
    <authorisedRepresentativeName>FISHER &amp; PAYKEL HEALTHCARE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000294</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010504</emdnCode>
    <emdnDescription>ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PT100EW</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:51:12.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>09420012410948</udiDi>
    <basicUdiDi>B-09420012410948</basicUdiDi>
    <tradeName>F&amp;P NEOPUFF</tradeName>
    <deviceName>T-Piece Resuscitator</deviceName>
    <manufacturerName>Fisher &amp; Paykel Healthcare Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000002556</manufacturerSrn>
    <authorisedRepresentativeName>FISHER &amp; PAYKEL HEALTHCARE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000294</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010504</emdnCode>
    <emdnDescription>ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD900AFU</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:51:10.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>09190001014067</udiDi>
    <basicUdiDi>B-09190001014067</basicUdiDi>
    <tradeName>09190001014067</tradeName>
    <deviceName>TwinStream SHFJV</deviceName>
    <manufacturerName>CARL REINER GmbH Medizintechnik für Diagnose und Therapie Manufaktur chirurgischer Instrumente</manufacturerName>
    <manufacturerSrn>AT-MF-000001504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010501</emdnCode>
    <emdnDescription>HIGH–FREQUENCY PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTNS-110-000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:37:47.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905930000156</udiDi>
    <basicUdiDi>B-08905930000156</basicUdiDi>
    <tradeName>Allied Meditec Vista</tradeName>
    <deviceName>HIGH–FREQUENCY PULMONARY VENTILATORS</deviceName>
    <manufacturerName>ALLIED MEDICAL LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000040690</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010501</emdnCode>
    <emdnDescription>HIGH–FREQUENCY PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>55000346</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:40:04.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>04064428001281</udiDi>
    <basicUdiDi>4064428FSOXYLOG600IC4U</basicUdiDi>
    <tradeName>04064428001281</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fritz Stephan GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007591</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010504</emdnCode>
    <emdnDescription>ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107161421</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:59:13.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>04064428001298</udiDi>
    <basicUdiDi>4064428FSOXYLOG600IC4U</basicUdiDi>
    <tradeName>04064428001298</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fritz Stephan GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007591</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010504</emdnCode>
    <emdnDescription>ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107161422</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:59:06.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198843002876</udiDi>
    <basicUdiDi>08479460BGBS</basicUdiDi>
    <tradeName>00198843002876</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZOLL Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000021386</manufacturerSrn>
    <authorisedRepresentativeName>ZOLL International Holding B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000012554</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010599</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR HOSPITAL USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>302.396.000-40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:48:38.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058647921921</udiDi>
    <basicUdiDi>B-08058647921921</basicUdiDi>
    <tradeName>Multilevel Night &amp; Day ST40V</tradeName>
    <deviceName>Multilevel Night &amp; Day ST40V</deviceName>
    <manufacturerName>Dima Italia S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000020327</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010504</emdnCode>
    <emdnDescription>ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST40V</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T19:05:27.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058647921914</udiDi>
    <basicUdiDi>B-08058647921914</basicUdiDi>
    <tradeName>Multilevel Night &amp; Day ST40</tradeName>
    <deviceName>Multilevel Night &amp; Day ST40</deviceName>
    <manufacturerName>Dima Italia S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000020327</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010504</emdnCode>
    <emdnDescription>ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST40</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T19:05:26.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058647921907</udiDi>
    <basicUdiDi>B-08058647921907</basicUdiDi>
    <tradeName>Multilevel Night &amp; Day ST30V</tradeName>
    <deviceName>Multilevel Night &amp; Day ST30V</deviceName>
    <manufacturerName>Dima Italia S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000020327</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010504</emdnCode>
    <emdnDescription>ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST30V</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T19:05:21.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058647921891</udiDi>
    <basicUdiDi>B-08058647921891</basicUdiDi>
    <tradeName>Multilevel Night &amp; Day ST30</tradeName>
    <deviceName>Multilevel Night &amp; Day ST30</deviceName>
    <manufacturerName>Dima Italia S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000020327</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010504</emdnCode>
    <emdnDescription>ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST30</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T19:05:20.688Z</lastUpdated>
  </row>
</eudamedExport>