<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03700512905219</udiDi>
    <basicUdiDi>037005129GSU-IAX9</basicUdiDi>
    <tradeName>03700512905219</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONG09499ST254</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T02:33:50.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512905264</udiDi>
    <basicUdiDi>037005129GSU-IAX9</basicUdiDi>
    <tradeName>03700512905264</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Y1500070</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T02:33:50.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512905301</udiDi>
    <basicUdiDi>037005129GSU-IAX9</basicUdiDi>
    <tradeName>03700512905301</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20325-011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T02:33:50.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512905318</udiDi>
    <basicUdiDi>037005129GSU-IAX9</basicUdiDi>
    <tradeName>03700512905318</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20325-010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T02:33:50.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512905325</udiDi>
    <basicUdiDi>037005129GSU-SEYF</basicUdiDi>
    <tradeName>03700512905325</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SMOKE EVACUATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20323-003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T02:33:49.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512905332</udiDi>
    <basicUdiDi>037005129GSU-SEYF</basicUdiDi>
    <tradeName>03700512905332</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SMOKE EVACUATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20323-006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T02:33:49.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512905479</udiDi>
    <basicUdiDi>037005129DEN7Y</basicUdiDi>
    <tradeName>03700512905479</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100-F43H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T02:33:49.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512905486</udiDi>
    <basicUdiDi>037005129DEN7Y</basicUdiDi>
    <tradeName>03700512905486</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100-F43</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T02:33:49.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512905493</udiDi>
    <basicUdiDi>037005129DEN7Y</basicUdiDi>
    <tradeName>03700512905493</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100-F63</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T02:33:49.907Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512905509</udiDi>
    <basicUdiDi>037005129DEN7Y</basicUdiDi>
    <tradeName>03700512905509</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100-G</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T02:33:49.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512905608</udiDi>
    <basicUdiDi>037005129INF-ESTT</basicUdiDi>
    <tradeName>03700512905608</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM000010B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T02:33:49.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512905615</udiDi>
    <basicUdiDi>037005129INF-ESTT</basicUdiDi>
    <tradeName>03700512905615</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM000011B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T02:33:49.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512905622</udiDi>
    <basicUdiDi>037005129INF-ESTT</basicUdiDi>
    <tradeName>03700512905622</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM000012B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T02:33:49.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512905646</udiDi>
    <basicUdiDi>037005129INF-ESTT</basicUdiDi>
    <tradeName>03700512905646</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM000011ARB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T02:33:49.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512905653</udiDi>
    <basicUdiDi>037005129INF-ESTT</basicUdiDi>
    <tradeName>03700512905653</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM000012ARB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T02:33:49.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512905660</udiDi>
    <basicUdiDi>037005129INF-ESTT</basicUdiDi>
    <tradeName>03700512905660</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM000020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T02:33:49.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512905677</udiDi>
    <basicUdiDi>037005129INF-ESTT</basicUdiDi>
    <tradeName>03700512905677</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM000021</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T02:33:49.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512905684</udiDi>
    <basicUdiDi>037005129INF-ESTT</basicUdiDi>
    <tradeName>03700512905684</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM000078</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T02:33:49.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512905691</udiDi>
    <basicUdiDi>037005129INF-ESTT</basicUdiDi>
    <tradeName>03700512905691</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM000073</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T02:33:49.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512905707</udiDi>
    <basicUdiDi>037005129INF-ESTT</basicUdiDi>
    <tradeName>03700512905707</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM000072</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T02:33:49.697Z</lastUpdated>
  </row>
</eudamedExport>