<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-FWD1510TW</udiDi>
    <basicUdiDi>B-FWD1510TW</basicUdiDi>
    <tradeName>D-FWD1510TW</tradeName>
    <deviceName>Sterile Film Wound Dressings</deviceName>
    <manufacturerName>Pharma Lab International Ltd.</manufacturerName>
    <manufacturerSrn>HK-MF-000013674</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04010202</emdnCode>
    <emdnDescription>POLYURETHANE FIXING DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FWD1510</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:29:55.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FWD1210TF</udiDi>
    <basicUdiDi>B-FWD1210TF</basicUdiDi>
    <tradeName>D-FWD1210TF</tradeName>
    <deviceName>Sterile Film Wound Dressings</deviceName>
    <manufacturerName>Pharma Lab International Ltd.</manufacturerName>
    <manufacturerSrn>HK-MF-000013674</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04010202</emdnCode>
    <emdnDescription>POLYURETHANE FIXING DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FWD1210</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:29:54.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FWD1210-10HN</udiDi>
    <basicUdiDi>B-FWD1210-10HN</basicUdiDi>
    <tradeName>D-FWD1210-10HN</tradeName>
    <deviceName>Sterile Film Wound Dressings</deviceName>
    <manufacturerName>Pharma Lab International Ltd.</manufacturerName>
    <manufacturerSrn>HK-MF-000013674</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04010202</emdnCode>
    <emdnDescription>POLYURETHANE FIXING DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FWD1210-10</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:29:52.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265023015</udiDi>
    <basicUdiDi>8907265H100ZP</basicUdiDi>
    <tradeName>INTRA SHIELD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons Group Private Limited Plant 6</manufacturerName>
    <manufacturerSrn>IN-MF-000053289</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M04010299</emdnCode>
    <emdnDescription>FIXING DRESSINGS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>GS-3045</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:10:55.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265023022</udiDi>
    <basicUdiDi>8907265H100ZP</basicUdiDi>
    <tradeName>INTRA SHIELD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons Group Private Limited Plant 6</manufacturerName>
    <manufacturerSrn>IN-MF-000053289</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M04010299</emdnCode>
    <emdnDescription>FIXING DRESSINGS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>GS-3045</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:10:50.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265023039</udiDi>
    <basicUdiDi>8907265H100ZP</basicUdiDi>
    <tradeName>INTRA SHIELD PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons Group Private Limited Plant 6</manufacturerName>
    <manufacturerSrn>IN-MF-000053289</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M04010299</emdnCode>
    <emdnDescription>FIXING DRESSINGS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>GS-3167</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:09:04.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265023046</udiDi>
    <basicUdiDi>8907265H100ZP</basicUdiDi>
    <tradeName>INTRA SHIELD PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons Group Private Limited Plant 6</manufacturerName>
    <manufacturerSrn>IN-MF-000053289</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M04010299</emdnCode>
    <emdnDescription>FIXING DRESSINGS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>GS-3167</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:08:35.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265023053</udiDi>
    <basicUdiDi>8907265H100ZP</basicUdiDi>
    <tradeName>FIX-O-CATH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons Group Private Limited Plant 6</manufacturerName>
    <manufacturerSrn>IN-MF-000053289</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M04010299</emdnCode>
    <emdnDescription>FIXING DRESSINGS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>GS-3179</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:07:20.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265023060</udiDi>
    <basicUdiDi>8907265H100ZP</basicUdiDi>
    <tradeName>FIX-O-CATH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons Group Private Limited Plant 6</manufacturerName>
    <manufacturerSrn>IN-MF-000053289</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M04010299</emdnCode>
    <emdnDescription>FIXING DRESSINGS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>GS-3179</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:06:22.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265023077</udiDi>
    <basicUdiDi>8907265H100ZP</basicUdiDi>
    <tradeName>FIX-O-CATH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons Group Private Limited Plant 6</manufacturerName>
    <manufacturerSrn>IN-MF-000053289</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M04010299</emdnCode>
    <emdnDescription>FIXING DRESSINGS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>GS-3179</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:05:19.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F19306WD</udiDi>
    <basicUdiDi>B-F19306WD</basicUdiDi>
    <tradeName>Pansement sparadrap microporeux renforcé NEO‐STERILE‐STRIPS® 6mmx7.5cm</tradeName>
    <deviceName>Pansement sparadrap microporeux renforcé NEO‐STERILE‐STRIPS® 6mmx7.5cm</deviceName>
    <manufacturerName>Adhe-Els SA.</manufacturerName>
    <manufacturerSrn>TN-MF-000011757</manufacturerSrn>
    <authorisedRepresentativeName>ADHE-ELS FRANCE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001654</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04010201</emdnCode>
    <emdnDescription>NON-WOVEN FIXING DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F19306</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:14:35.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F19305WB</udiDi>
    <basicUdiDi>B-F19305WB</basicUdiDi>
    <tradeName>Pansement sparadrap microporeux renforcé NEO‐STERILE‐STRIPS® 3mmx7.5cm</tradeName>
    <deviceName>Pansement sparadrap microporeux renforcé NEO‐STERILE‐STRIPS® 3mmx7.5cm</deviceName>
    <manufacturerName>Adhe-Els SA.</manufacturerName>
    <manufacturerSrn>TN-MF-000011757</manufacturerSrn>
    <authorisedRepresentativeName>ADHE-ELS FRANCE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001654</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04010201</emdnCode>
    <emdnDescription>NON-WOVEN FIXING DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F19305</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:14:34.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F19304W9</udiDi>
    <basicUdiDi>B-F19304W9</basicUdiDi>
    <tradeName>Pansement sparadrap microporeux renforcé NEO‐STERILE‐STRIPS® 6mm x 3,8cm</tradeName>
    <deviceName>Pansement sparadrap microporeux renforcé NEO‐STERILE‐STRIPS® 6mm x 3,8cm</deviceName>
    <manufacturerName>Adhe-Els SA.</manufacturerName>
    <manufacturerSrn>TN-MF-000011757</manufacturerSrn>
    <authorisedRepresentativeName>ADHE-ELS FRANCE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001654</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04010201</emdnCode>
    <emdnDescription>NON-WOVEN FIXING DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F19304</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:14:33.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F19300VZ</udiDi>
    <basicUdiDi>B-F19300VZ</basicUdiDi>
    <tradeName>Pansement sparadrap microporeux renforcé NEO‐STERILE‐STRIPS® 12,5mm x 10cm</tradeName>
    <deviceName>Pansement sparadrap microporeux renforcé NEO‐STERILE‐STRIPS® 12,5mm x 10cm</deviceName>
    <manufacturerName>Adhe-Els SA.</manufacturerName>
    <manufacturerSrn>TN-MF-000011757</manufacturerSrn>
    <authorisedRepresentativeName>ADHE-ELS FRANCE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001654</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04010201</emdnCode>
    <emdnDescription>NON-WOVEN FIXING DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F19300</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:14:29.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F16003V3</udiDi>
    <basicUdiDi>B-F16003V3</basicUdiDi>
    <tradeName>Pansement adhésif non‐tissé avec compresse absorbante Fixaderm stérile® 8x12cm E.5pc</tradeName>
    <deviceName>Pansement adhésif non‐tissé avec compresse absorbante Fixaderm stérile® 8x12cm E.5pc</deviceName>
    <manufacturerName>Adhe-Els SA.</manufacturerName>
    <manufacturerSrn>TN-MF-000011757</manufacturerSrn>
    <authorisedRepresentativeName>ADHE-ELS FRANCE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001654</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04010202</emdnCode>
    <emdnDescription>POLYURETHANE FIXING DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F16003</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:13:42.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223003736576</udiDi>
    <basicUdiDi>62220238TubifixPW</basicUdiDi>
    <tradeName>TUBIFIX Family</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pharmaplast</manufacturerName>
    <manufacturerSrn>EG-MF-000004501</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04010201</emdnCode>
    <emdnDescription>NON-WOVEN FIXING DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>920507</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:09:48.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223003736583</udiDi>
    <basicUdiDi>62220238TubifixPW</basicUdiDi>
    <tradeName>TUBIFIX Family</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pharmaplast</manufacturerName>
    <manufacturerSrn>EG-MF-000004501</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04010201</emdnCode>
    <emdnDescription>NON-WOVEN FIXING DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>920402</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:09:48.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223003736590</udiDi>
    <basicUdiDi>62220238TubifixPW</basicUdiDi>
    <tradeName>TUBIFIX Family</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pharmaplast</manufacturerName>
    <manufacturerSrn>EG-MF-000004501</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04010201</emdnCode>
    <emdnDescription>POLYURETHANE FIXING DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>920401</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:09:48.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223004863738</udiDi>
    <basicUdiDi>62220238TubifixPW</basicUdiDi>
    <tradeName>TUBIFIX Family</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pharmaplast</manufacturerName>
    <manufacturerSrn>EG-MF-000004501</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04010201</emdnCode>
    <emdnDescription>NON-WOVEN FIXING DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>920508</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:08:48.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926365556171</udiDi>
    <basicUdiDi>692636550000274</basicUdiDi>
    <tradeName>CEKA PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Longterm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001161</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04010202</emdnCode>
    <emdnDescription>NON-WOVEN FIXING DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:29:03.981Z</lastUpdated>
  </row>
</eudamedExport>