<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03700512926276</udiDi>
    <basicUdiDi>037005129INF-ESTT</basicUdiDi>
    <tradeName>03700512926276</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>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM000093</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T17:57:55.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512926283</udiDi>
    <basicUdiDi>037005129INF-ESTT</basicUdiDi>
    <tradeName>03700512926283</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>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM000094</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T17:57:55.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512926429</udiDi>
    <basicUdiDi>037005129GSU-IAX9</basicUdiDi>
    <tradeName>03700512926429</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>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1100037</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T17:57:55.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512926436</udiDi>
    <basicUdiDi>037005129GSU-IAX9</basicUdiDi>
    <tradeName>03700512926436</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>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1502152</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T17:57:55.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512926603</udiDi>
    <basicUdiDi>037005129INF-ESTT</basicUdiDi>
    <tradeName>03700512926603</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>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFX-102Y</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T17:57:55.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512926610</udiDi>
    <basicUdiDi>037005129INF-ESTT</basicUdiDi>
    <tradeName>03700512926610</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>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFX-103Y</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T17:57:55.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512926627</udiDi>
    <basicUdiDi>037005129INF-ESTT</basicUdiDi>
    <tradeName>03700512926627</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>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X100-AS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T17:57:55.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512926634</udiDi>
    <basicUdiDi>037005129INF-ESTT</basicUdiDi>
    <tradeName>03700512926634</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>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X150-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T17:57:54.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512926658</udiDi>
    <basicUdiDi>037005129GSU-IAX9</basicUdiDi>
    <tradeName>03700512926658</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>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SI.10.330.005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T17:57:54.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512926993</udiDi>
    <basicUdiDi>037005129ACC06N2</basicUdiDi>
    <tradeName>03700512926993</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>A03020101</emdnCode>
    <emdnDescription>LOW PRESSURE EXTENSION LINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODG0702SC167</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T17:57:54.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>06943771610006</udiDi>
    <basicUdiDi>B-06943771610006</basicUdiDi>
    <tradeName>06943771610006</tradeName>
    <deviceName>Pulse Lavage Drainage Device</deviceName>
    <manufacturerName>Beijing Wanjie Medical Device Corporation Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000027478</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WJ-06</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-21T05:29:07.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958697623047</udiDi>
    <basicUdiDi>69586976HWDFSYQ0019G</basicUdiDi>
    <tradeName>ICOPIUMA Infusion sets for single use</tradeName>
    <deviceName>Infusion sets for single use (DEHP free)</deviceName>
    <manufacturerName>Anhui Hongyu Wuzhou Medical Manufacturer CO.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029789</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7780820</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:38:08.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958697623054</udiDi>
    <basicUdiDi>69586976HWDFSYQ0019G</basicUdiDi>
    <tradeName>ICOPIUMA Infusion sets for single use</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Anhui Hongyu Wuzhou Medical Manufacturer CO.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029789</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7780821</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:29:49.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IS407003-OC7</udiDi>
    <basicUdiDi>B-IS407003-OC7</basicUdiDi>
    <tradeName>INFUSET</tradeName>
    <deviceName>INFUSET - Deflussore microgoccia 3 vie</deviceName>
    <manufacturerName>Know Medical Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000013457</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03010101</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH OR W/O AIR INLET</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS407003-O</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-20T20:01:59.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>08049033196474</udiDi>
    <basicUdiDi>B-08049033196474</basicUdiDi>
    <tradeName>BURETTE</tradeName>
    <deviceName>BURETTE - Buretta per infusione 100ml</deviceName>
    <manufacturerName>Know Medical Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000013457</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BG100600-O</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-20T20:01:36.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223004250132</udiDi>
    <basicUdiDi>622300425IVS1009Z3</basicUdiDi>
    <tradeName>ULTRAMED I.V. INFUSION SET With Flow Regulator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)</manufacturerName>
    <manufacturerSrn>EG-MF-000038562</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A03010101</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1013</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-20T13:57:44.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223004250149</udiDi>
    <basicUdiDi>622300425IVS1009Z3</basicUdiDi>
    <tradeName>ULTRAMED I.V. INFUSION SET Micro Drip I.V.Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)</manufacturerName>
    <manufacturerSrn>EG-MF-000038562</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A03010101</emdnCode>
    <emdnDescription>INFUSION MICRO-CONTROLLERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1012</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-20T13:57:44.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223004250248</udiDi>
    <basicUdiDi>622300425EXT1011XP</basicUdiDi>
    <tradeName>ULTRAMED EXTENSION TUBE Low Pressure Without 3 Way Stop Cock - 10 cm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)</manufacturerName>
    <manufacturerSrn>EG-MF-000038562</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A03020101</emdnCode>
    <emdnDescription>LOW PRESSURE EXTENSION LINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1011/LP-10</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-20T13:57:44.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223004250255</udiDi>
    <basicUdiDi>622300425EXT1011XP</basicUdiDi>
    <tradeName>ULTRAMED EXTENSION TUBE Low Pressure Without 3 Way Stop Cock - 15 cm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)</manufacturerName>
    <manufacturerSrn>EG-MF-000038562</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A03020101</emdnCode>
    <emdnDescription>LOW PRESSURE EXTENSION LINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1011/LP-15</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-20T13:57:44.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223004250262</udiDi>
    <basicUdiDi>622300425EXT1011XP</basicUdiDi>
    <tradeName>ULTRAMED EXTENSION TUBE Low Pressure Without 3 Way Stop Cock - 25 cm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)</manufacturerName>
    <manufacturerSrn>EG-MF-000038562</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A03020101</emdnCode>
    <emdnDescription>LOW PRESSURE EXTENSION LINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1011/LP-25</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-20T13:57:44.118Z</lastUpdated>
  </row>
</eudamedExport>