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<eudamedExport entity="devices">
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    <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>
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  <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>
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  <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>04048675250418</udiDi>
    <basicUdiDi>B-04048675250418</basicUdiDi>
    <tradeName>Workstation NC</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>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8417400</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T23:56:33.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927116600495</udiDi>
    <basicUdiDi>69271166000002VKK</basicUdiDi>
    <tradeName>Neonatal Ventilator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Northern Meditec Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000013521</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:43:34.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970658140196</udiDi>
    <basicUdiDi>B-06970658140196</basicUdiDi>
    <tradeName>Nasal Continuous Positive Airway Pressure System</tradeName>
    <deviceName>Nasal Continuous Positive Airway Pressure System</deviceName>
    <manufacturerName>Ambulanc (Shenzhen) Tech. Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010435</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>68B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:29:55.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429060959</udiDi>
    <basicUdiDi>69454290VN001RK</basicUdiDi>
    <tradeName>Neonatal and Pediatric Ventilators</tradeName>
    <deviceName>Neonatal and Pediatric Ventilators</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VN8S HFO</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:29:55.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429060942</udiDi>
    <basicUdiDi>69454290VN001RK</basicUdiDi>
    <tradeName>Neonatal and Pediatric Ventilators</tradeName>
    <deviceName>Neonatal and Pediatric Ventilators</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VN8</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:29:52.020Z</lastUpdated>
  </row>
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    <udiDi>06945429060935</udiDi>
    <basicUdiDi>69454290VN001RK</basicUdiDi>
    <tradeName>Neonatal and Pediatric Ventilators</tradeName>
    <deviceName>Neonatal and Pediatric Ventilators</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VN8S</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:29:49.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429060911</udiDi>
    <basicUdiDi>69454290VN001RK</basicUdiDi>
    <tradeName>Neonatal and Pediatric Ventilators</tradeName>
    <deviceName>Neonatal and Pediatric Ventilators</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VN6S HFO</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:29:48.471Z</lastUpdated>
  </row>
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