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<eudamedExport entity="devices">
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    <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>
  </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>05051223028062</udiDi>
    <basicUdiDi>B-05051223028062</basicUdiDi>
    <tradeName>Monopolar Babcock Forceps with On/Off Ratchet, 5mm/33cm</tradeName>
    <deviceName>Monopolar Babcock Forceps</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010602</emdnCode>
    <emdnDescription>LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS4559P</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:11:03.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223024712</udiDi>
    <basicUdiDi>B-05051223024712</basicUdiDi>
    <tradeName>Loop Electrode, Large, 20mm x 20mmØ</tradeName>
    <deviceName>Loop Electrode</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0201010301</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS9168</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:11:02.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223023159</udiDi>
    <basicUdiDi>B-05051223023159</basicUdiDi>
    <tradeName>Reloadable Linear Stapler with Indicator 60 × 4.8 mm</tradeName>
    <deviceName>Reloadable Linear Stapler</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H020201010102</emdnCode>
    <emdnDescription>SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITHOUT BLADE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS9LSI60G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:10:58.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223009177</udiDi>
    <basicUdiDi>B-05051223009177</basicUdiDi>
    <tradeName>Skin Marker, Standard Tip Plus Label</tradeName>
    <deviceName>Skin Market, Standard Tip, with Label</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V9004</emdnCode>
    <emdnDescription>SKIN MARKING DERMOGRAPHIC PENCILS AND PENS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS3150L</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:10:57.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223004462</udiDi>
    <basicUdiDi>B-05051223004462</basicUdiDi>
    <tradeName>Electrode Tip Cleaner</tradeName>
    <deviceName>Electrode Tip Cleaner</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0299</emdnCode>
    <emdnDescription>ELECTROSURGERY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS5204</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:10:56.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719873185252</udiDi>
    <basicUdiDi>B-04719873185252</basicUdiDi>
    <tradeName>Bomei Anchorage screw</tradeName>
    <deviceName>Non Sterile Orthodontic Anchorage Screw</deviceName>
    <manufacturerName>BOMEI Co.,Ltd</manufacturerName>
    <manufacturerSrn>TW-MF-000013725</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM-2103-0</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:03:32.181Z</lastUpdated>
  </row>
</eudamedExport>