<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05056682200592</udiDi>
    <basicUdiDi>505668220EmollientsUG</basicUdiDi>
    <tradeName>Aquasoothe 1%</tradeName>
    <deviceName>Emollient Creams</deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQUA1CREAM100GRAM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:00:51.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200127</udiDi>
    <basicUdiDi>505668220BarriercreamW6</basicUdiDi>
    <tradeName>Derma Protective Plus Skin Protectant</tradeName>
    <deviceName>Derma Protective Plus Skin Protectant</deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DERMA115PROTUBE</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:00:51.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200011</udiDi>
    <basicUdiDi>505668220ScartreatmentN2</basicUdiDi>
    <tradeName>Silconex Scar Treatment Gel</tradeName>
    <deviceName>Silconex Scar Treatment Gel</deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SILCONEX15GM</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:00:50.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682201018</udiDi>
    <basicUdiDi>505668220EmollientsUG</basicUdiDi>
    <tradeName>Enopen</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENOPENCREAM1050GM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:43.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200707</udiDi>
    <basicUdiDi>505668220EmollientsUG</basicUdiDi>
    <tradeName>Enopen</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENOPENCREAM500GM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:42.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200684</udiDi>
    <basicUdiDi>505668220EmollientsUG</basicUdiDi>
    <tradeName>Enopen</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENOPENCREAM150GM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:41.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200677</udiDi>
    <basicUdiDi>505668220EmollientsUG</basicUdiDi>
    <tradeName>Enopen</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENOPENCREAM50GM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:41.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200660</udiDi>
    <basicUdiDi>505668220EmollientsUG</basicUdiDi>
    <tradeName>Thirty:30</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THIRTY30OIN125GRAM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:40.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200653</udiDi>
    <basicUdiDi>505668220EmollientsUG</basicUdiDi>
    <tradeName>Thirty30</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THIRTY30OIN500GRAM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:39.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200646</udiDi>
    <basicUdiDi>505668220EmollientsUG</basicUdiDi>
    <tradeName>Emulsifying Ointment</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EMULSIOINT500GRAM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:38.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200639</udiDi>
    <basicUdiDi>505668220EmollientsUG</basicUdiDi>
    <tradeName>Fifty:50</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIFTY50OINT250GRAM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:37.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200622</udiDi>
    <basicUdiDi>505668220EmollientsUG</basicUdiDi>
    <tradeName>Fifty:50</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIFTY50OINT500GRAM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:36.571Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200615</udiDi>
    <basicUdiDi>505668220EmollientsUG</basicUdiDi>
    <tradeName>Aquasoothe 2%</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQUA2CREAM500GRAM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:35.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200608</udiDi>
    <basicUdiDi>505668220EmollientsUG</basicUdiDi>
    <tradeName>Aquasoothe 1%</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQUA1CREAM500GRAM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:34.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200110</udiDi>
    <basicUdiDi>505668220ScartreatmentN2</basicUdiDi>
    <tradeName>Silconex Scar Treatment Gel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SILCONEX15GMAR</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:32.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200103</udiDi>
    <basicUdiDi>505668220ScartreatmentN2</basicUdiDi>
    <tradeName>Silconex Scar Treatment Gel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SILCONEX6GM</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:31.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056682200042</udiDi>
    <basicUdiDi>505668220ScartreatmentN2</basicUdiDi>
    <tradeName>Silconex Scar Treatment Gel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ennogen Healthcare International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000039877</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SILCONEX6GMAR</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T15:26:30.258Z</lastUpdated>
  </row>
</eudamedExport>