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<eudamedExport entity="devices">
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    <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>04897122901515</udiDi>
    <basicUdiDi>B-04897122901515</basicUdiDi>
    <tradeName>Medicare</tradeName>
    <deviceName>Pulse Oximeters</deviceName>
    <manufacturerName>Fleming Medical Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014750</manufacturerSrn>
    <authorisedRepresentativeName>Fleming Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000012571</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020302</emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD1913</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:17:42.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>04897122901034</udiDi>
    <basicUdiDi>B-04897122901034</basicUdiDi>
    <tradeName>Medicare</tradeName>
    <deviceName>A3-Wrist Blood Pressure Monitor Wireless</deviceName>
    <manufacturerName>Fleming Medical Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014750</manufacturerSrn>
    <authorisedRepresentativeName>Fleming Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000012571</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020302</emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD1810</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:17:37.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>04897122901027</udiDi>
    <basicUdiDi>B-04897122901027</basicUdiDi>
    <tradeName>Medicare</tradeName>
    <deviceName>A4-Blood Pressure Monitor Wireless</deviceName>
    <manufacturerName>Fleming Medical Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014750</manufacturerSrn>
    <authorisedRepresentativeName>Fleming Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000012571</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020302</emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD1809</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:17:37.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>04897122901010</udiDi>
    <basicUdiDi>B-04897122901010</basicUdiDi>
    <tradeName>Medicare</tradeName>
    <deviceName>A6-Blood Pressure Monitor Wireless</deviceName>
    <manufacturerName>Fleming Medical Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014750</manufacturerSrn>
    <authorisedRepresentativeName>Fleming Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000012571</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020302</emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD1808</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:17:35.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895045403833</udiDi>
    <basicUdiDi>B-04895045403833</basicUdiDi>
    <tradeName>04895045403833</tradeName>
    <deviceName>Digital Automatic Blood Pressure Monitor</deviceName>
    <manufacturerName>Grandway Technology (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000009310</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020302</emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD5200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:16:28.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>04895045403499</udiDi>
    <basicUdiDi>B-04895045403499</basicUdiDi>
    <tradeName>04895045403499</tradeName>
    <deviceName>Digital Automatic Blood Pressure Monitor</deviceName>
    <manufacturerName>Grandway Technology (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000009310</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020302</emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD3111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:16:28.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972911370005</udiDi>
    <basicUdiDi>697291137YM4A</basicUdiDi>
    <tradeName>Fingertip Pulse Oximeter</tradeName>
    <deviceName>Fingertip Pulse Oximeter</deviceName>
    <manufacturerName>Shenzhen Yimi Life Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000029928</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020408</emdnCode>
    <emdnDescription>PULSE OXIMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YM102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:09:21.852Z</lastUpdated>
  </row>
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