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<eudamedExport entity="devices">
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    <basicUdiDi>5051380N2328EY</basicUdiDi>
    <tradeName>Balloon Test Lung - Single Use - Qty 1</tradeName>
    <deviceName>Test Lungs</deviceName>
    <manufacturerName>SLE Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004155</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010580</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR HOSPITAL USE - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N2328</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:02:28.585Z</lastUpdated>
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    <udiDi>05051380010436</udiDi>
    <basicUdiDi>5051380LIFESTART95</basicUdiDi>
    <tradeName>LifeStart™ (230V)</tradeName>
    <deviceName>LifeStart™</deviceName>
    <manufacturerName>SLE Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004155</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080405</emdnCode>
    <emdnDescription>NEONATAL RESUSCITATION BEDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LSU003US</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:02:26.310Z</lastUpdated>
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  <row>
    <udiDi>05051380009317</udiDi>
    <basicUdiDi>B-05051380009317</basicUdiDi>
    <tradeName>SLE6000 - Sweden (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>2026-07-06T05:12:00.321Z</lastUpdated>
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    <udiDi>05051380007092</udiDi>
    <basicUdiDi>B-05051380007092</basicUdiDi>
    <tradeName>SLE6000 - Norway (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>2026-07-06T05:11:56.232Z</lastUpdated>
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  <row>
    <udiDi>05051380006347</udiDi>
    <basicUdiDi>B-05051380006347</basicUdiDi>
    <tradeName>SLE6000 - Netherlands (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>2026-07-06T05:11:55.431Z</lastUpdated>
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  <row>
    <udiDi>05051380006323</udiDi>
    <basicUdiDi>B-05051380006323</basicUdiDi>
    <tradeName>SLE6000 - Spain (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>2026-07-06T05:11:54.633Z</lastUpdated>
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  <row>
    <udiDi>05051380006316</udiDi>
    <basicUdiDi>B-05051380006316</basicUdiDi>
    <tradeName>SLE6000 - Romania (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>2026-07-06T05:11:53.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380006231</udiDi>
    <basicUdiDi>B-05051380006231</basicUdiDi>
    <tradeName>SLE6000 - Slovenia (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>2026-07-06T05:11:50.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380006224</udiDi>
    <basicUdiDi>B-05051380006224</basicUdiDi>
    <tradeName>SLE6000 - Slovakia (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>2026-07-06T05:11:50.470Z</lastUpdated>
  </row>
  <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>
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  <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>
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  <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>
</eudamedExport>