<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>05051380010443</udiDi>
    <basicUdiDi>5051380LIFESTART95</basicUdiDi>
    <tradeName>LifeStart™ (110V)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SLE Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004155</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080405</emdnCode>
    <emdnDescription>NEONATAL RESUSCITATION BEDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LSU003</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:04:34.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380010450</udiDi>
    <basicUdiDi>5051380LIFESTART95</basicUdiDi>
    <tradeName>LifeStart™ (230V)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SLE Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004155</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080405</emdnCode>
    <emdnDescription>NEONATAL RESUSCITATION BEDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LSU003a</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:04:34.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380013666</udiDi>
    <basicUdiDi>5051380N2328EY</basicUdiDi>
    <tradeName>Balloon Test Lung - Single Use - Qty 10</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SLE Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004155</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203010580</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR HOSPITAL USE - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N2328/10</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:04:34.712Z</lastUpdated>
  </row>
</eudamedExport>