<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05051380006309</udiDi>
    <basicUdiDi>B-05051380006309</basicUdiDi>
    <tradeName>SLE6000 - Italy (Packaging)</tradeName>
    <deviceName>SLE6000 Infant Ventilator</deviceName>
    <manufacturerName>SLE Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004155</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z6000</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:11:50.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380006293</udiDi>
    <basicUdiDi>B-05051380006293</basicUdiDi>
    <tradeName>SLE6000 - France (Packaging)</tradeName>
    <deviceName>SLE6000 Infant Ventilator</deviceName>
    <manufacturerName>SLE Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004155</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z6000</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:11:47.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380006217</udiDi>
    <basicUdiDi>B-05051380006217</basicUdiDi>
    <tradeName>SLE6000 - Portugal (Packaging)</tradeName>
    <deviceName>SLE6000 Infant Ventilator</deviceName>
    <manufacturerName>SLE Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004155</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z6000</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:11:30.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380006200</udiDi>
    <basicUdiDi>B-05051380006200</basicUdiDi>
    <tradeName>SLE6000 - Poland (Packaging)</tradeName>
    <deviceName>SLE6000 Infant Ventilator</deviceName>
    <manufacturerName>SLE Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004155</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z6000</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:11:29.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380006194</udiDi>
    <basicUdiDi>B-05051380006194</basicUdiDi>
    <tradeName>SLE6000 - Hungary (Packaging)</tradeName>
    <deviceName>SLE6000 Infant Ventilator</deviceName>
    <manufacturerName>SLE Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004155</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z6000</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:11:28.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380006187</udiDi>
    <basicUdiDi>B-05051380006187</basicUdiDi>
    <tradeName>SLE6000 - Greece (Packaging)</tradeName>
    <deviceName>SLE6000 Infant Ventilator</deviceName>
    <manufacturerName>SLE Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004155</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z6000</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:11:28.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380006170</udiDi>
    <basicUdiDi>B-05051380006170</basicUdiDi>
    <tradeName>SLE6000 - Germany (Packaging)</tradeName>
    <deviceName>SLE6000 Infant Ventilator</deviceName>
    <manufacturerName>SLE Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004155</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z6000</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:11:24.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380006163</udiDi>
    <basicUdiDi>B-05051380006163</basicUdiDi>
    <tradeName>SLE6000 - Czech (Packaging)</tradeName>
    <deviceName>SLE6000 Infant Ventilator</deviceName>
    <manufacturerName>SLE Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004155</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z6000</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:11:23.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380006156</udiDi>
    <basicUdiDi>B-05051380006156</basicUdiDi>
    <tradeName>SLE6000 - Denmark (Packaging)</tradeName>
    <deviceName>SLE6000 Infant Ventilator</deviceName>
    <manufacturerName>SLE Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004155</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z6000</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:11:22.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380006149</udiDi>
    <basicUdiDi>B-05051380006149</basicUdiDi>
    <tradeName>SLE6000 - Croatia (Packaging)</tradeName>
    <deviceName>SLE6000 Infant Ventilator</deviceName>
    <manufacturerName>SLE Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004155</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z6000</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:11:21.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380006132</udiDi>
    <basicUdiDi>B-05051380006132</basicUdiDi>
    <tradeName>SLE6000 - United Kingdom (Packaging)</tradeName>
    <deviceName>SLE6000 Infant Ventilator</deviceName>
    <manufacturerName>SLE Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004155</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z6000</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:11:17.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380003056</udiDi>
    <basicUdiDi>B-05051380003056</basicUdiDi>
    <tradeName>SLE6000 - (Device)</tradeName>
    <deviceName>SLE6000 Infant Ventilator</deviceName>
    <manufacturerName>SLE Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004155</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z6000</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:11:16.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904090597</udiDi>
    <basicUdiDi>69449040AB010000073C</basicUdiDi>
    <tradeName>Flow Sensor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203010585</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR HOSPITAL USE - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040-001949-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:23.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904090870</udiDi>
    <basicUdiDi>69449040AB010000073C</basicUdiDi>
    <tradeName>Flow Sensor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203010585</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR HOSPITAL USE - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040-001947-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:23.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904090887</udiDi>
    <basicUdiDi>69449040AB010000073C</basicUdiDi>
    <tradeName>Flow Sensor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203010585</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR HOSPITAL USE - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040-001948-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:23.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904090894</udiDi>
    <basicUdiDi>69449040AB010000073C</basicUdiDi>
    <tradeName>Flow Sensor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203010585</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR HOSPITAL USE - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040-001950-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:03.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048675422495</udiDi>
    <basicUdiDi>B-04048675422495</basicUdiDi>
    <tradeName>Einweg Exp. Valve Carina</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010585</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR HOSPITAL USE - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP00220</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:01:02.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048675422471</udiDi>
    <basicUdiDi>B-04048675422471</basicUdiDi>
    <tradeName>SyncVent Carina</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010585</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR HOSPITAL USE - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP00224</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:00:58.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048675420378</udiDi>
    <basicUdiDi>B-04048675420378</basicUdiDi>
    <tradeName>Einweg ExVentil Evita WF</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010585</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR HOSPITAL USE - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP02600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T23:58:54.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048675411628</udiDi>
    <basicUdiDi>B-04048675411628</basicUdiDi>
    <tradeName>Savina 300</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</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>8417801</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T23:58:02.017Z</lastUpdated>
  </row>
</eudamedExport>