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<eudamedExport entity="devices">
  <row>
    <udiDi>05051380008808</udiDi>
    <basicUdiDi>B-05051380008808</basicUdiDi>
    <tradeName>SLE6000N - Slovakia (Packaging)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SLE Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004155</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z6000N</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:03:51.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380008785</udiDi>
    <basicUdiDi>B-05051380008785</basicUdiDi>
    <tradeName>SLE6000N - 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>Z6000N</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:03:50.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380008778</udiDi>
    <basicUdiDi>B-05051380008778</basicUdiDi>
    <tradeName>SLE6000N - 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>Z6000N</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:03:49.625Z</lastUpdated>
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  <row>
    <udiDi>05051380008761</udiDi>
    <basicUdiDi>B-05051380008761</basicUdiDi>
    <tradeName>SLE6000N - 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>Z6000N</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:03:48.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380008754</udiDi>
    <basicUdiDi>B-05051380008754</basicUdiDi>
    <tradeName>SLE6000N - 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>Z6000N</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:03:48.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380008730</udiDi>
    <basicUdiDi>B-05051380008730</basicUdiDi>
    <tradeName>SLE6000N - 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>Z6000N</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:03:44.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380008723</udiDi>
    <basicUdiDi>B-05051380008723</basicUdiDi>
    <tradeName>SLE6000N - 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>Z6000N</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:03:43.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380008716</udiDi>
    <basicUdiDi>B-05051380008716</basicUdiDi>
    <tradeName>SLE6000N - 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>Z6000N</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:03:42.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380008709</udiDi>
    <basicUdiDi>B-05051380008709</basicUdiDi>
    <tradeName>SLE6000N - 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>Z6000N</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:03:41.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380008693</udiDi>
    <basicUdiDi>B-05051380008693</basicUdiDi>
    <tradeName>SLE6000N - 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>Z6000N</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:03:37.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380008686</udiDi>
    <basicUdiDi>B-05051380008686</basicUdiDi>
    <tradeName>SLE6000N - 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>Z6000N</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:03:36.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380008679</udiDi>
    <basicUdiDi>B-05051380008679</basicUdiDi>
    <tradeName>SLE6000N - 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>Z6000N</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:03:36.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380008662</udiDi>
    <basicUdiDi>B-05051380008662</basicUdiDi>
    <tradeName>SLE6000N - 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>Z6000N</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:03:35.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380007481</udiDi>
    <basicUdiDi>B-05051380007481</basicUdiDi>
    <tradeName>SLE6000C - (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>Z6000C</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:03:31.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380007474</udiDi>
    <basicUdiDi>B-05051380007474</basicUdiDi>
    <tradeName>SLE6000N - (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>Z6000N</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:03:30.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380005517</udiDi>
    <basicUdiDi>B-05051380005517</basicUdiDi>
    <tradeName>Flow Sensor - Single Use - Qty 1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SLE Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004155</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203010580</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR HOSPITAL USE - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N5302</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:03:17.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380004169</udiDi>
    <basicUdiDi>B-05051380004169</basicUdiDi>
    <tradeName>Flow Sensor - Single Use - Qty 50</tradeName>
    <deviceName>Flow Sensor</deviceName>
    <manufacturerName>SLE Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004155</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010580</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR HOSPITAL USE - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N5302/50</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:03:15.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380004152</udiDi>
    <basicUdiDi>B-05051380004152</basicUdiDi>
    <tradeName>Flow Sensor - Single Use - Qty 5</tradeName>
    <deviceName>Flow Sensor</deviceName>
    <manufacturerName>SLE Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004155</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010580</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR HOSPITAL USE - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N5302/05</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:03:13.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380001656</udiDi>
    <basicUdiDi>B-05051380001656</basicUdiDi>
    <tradeName>Flow Sensor - Reusable - Qty 1</tradeName>
    <deviceName>Flow Sensor</deviceName>
    <manufacturerName>SLE Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004155</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010580</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR HOSPITAL USE - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N5402-REV2</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:03:12.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051380000895</udiDi>
    <basicUdiDi>5051380N6647GF</basicUdiDi>
    <tradeName>Bellow Test Lung - Resuable - 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>Z1203019080</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N6647</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:02:29.385Z</lastUpdated>
  </row>
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