<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>09333279000015</udiDi>
    <basicUdiDi>9333279FLEXINOZER</basicUdiDi>
    <tradeName>Flexi Nozzles (short)</tradeName>
    <deviceName>Administration Kit</deviceName>
    <manufacturerName>ENT Technologies Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000050290</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A030499</emdnCode>
    <emdnDescription>ADMINISTRATION KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLX-ENT-S</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:04:24.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>05070000280707</udiDi>
    <basicUdiDi>50700002807Poc-KIT966DD</basicUdiDi>
    <tradeName>Poc-KIT Stretcher</tradeName>
    <deviceName>Poc-KIT Stretcher</deviceName>
    <manufacturerName>Garmentec Group Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000015646</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>EMERGENCY AND TRAUMATOLOGY STRETCHERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>966</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:47:58.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060602250697</udiDi>
    <basicUdiDi>506060225INOV8-048P5</basicUdiDi>
    <tradeName>Tote Timer</tradeName>
    <deviceName>Elapsed Time Indication Label</deviceName>
    <manufacturerName>Meditech Endoscopy Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000014143</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INOV8-048</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:24:27.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060602250604</udiDi>
    <basicUdiDi>506060225INOV8-017NS</basicUdiDi>
    <tradeName>ColoGrip</tradeName>
    <deviceName>Device Grip</deviceName>
    <manufacturerName>Meditech Endoscopy Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000014143</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INOV8-014</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:24:26.797Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060602250031</udiDi>
    <basicUdiDi>5060602250031PG</basicUdiDi>
    <tradeName>StageOne (Neutral)</tradeName>
    <deviceName>StageOne N</deviceName>
    <manufacturerName>Meditech Endoscopy Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000014143</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011301</emdnCode>
    <emdnDescription>CLEANING AND DISINFECTION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INOV8-009</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:24:25.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060602250017</udiDi>
    <basicUdiDi>5060602250017PN</basicUdiDi>
    <tradeName>ValveSafe</tradeName>
    <deviceName>Valvesafe</deviceName>
    <manufacturerName>Meditech Endoscopy Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000014143</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S010499</emdnCode>
    <emdnDescription>STERILISATION CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INOV8-001</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:24:23.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060411670044</udiDi>
    <basicUdiDi>506041167VAPOCOOLANTWE</basicUdiDi>
    <tradeName>Dermogesic Non-flammable Cold Spray (Direct Stream)</tradeName>
    <deviceName>Cryogesic Fine Spray</deviceName>
    <manufacturerName>Vitame Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000015647</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CRYOTHERAPY AND THERMOTHERAPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DERMOGESIC100M</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:13:49.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060254924533</udiDi>
    <basicUdiDi>506025492BarriercreamPD</basicUdiDi>
    <tradeName>Derma Protective Plus</tradeName>
    <deviceName>Derma Protective Plus</deviceName>
    <manufacturerName>Ennogen Healthcare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000022280</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INCONTINENCE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DERMA115PROTUBE</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:10:54.571Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060254920191</udiDi>
    <basicUdiDi>506025492EmollientsP3</basicUdiDi>
    <tradeName>Fifty:50 Ointment 250g</tradeName>
    <deviceName>Thirty:30 125g</deviceName>
    <manufacturerName>Ennogen Healthcare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000022280</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>Artık piyasada değil</deviceStatus>
    <reference>FIFTY50OINT250GRAM</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:10:53.819Z</lastUpdated>
  </row>
  <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>00047701500026</udiDi>
    <basicUdiDi>506001888DNTKREPAIR001ZN</basicUdiDi>
    <tradeName>Temparin Max Repair Kit 12+ (2.64g)</tradeName>
    <deviceName>Dental Repair Kits</deviceName>
    <manufacturerName>DenTek Oral Care Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034440</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0101010203</emdnCode>
    <emdnDescription>TEMPORARY DENTAL CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05000200101F</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:58:30.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>00047701000175</udiDi>
    <basicUdiDi>506001888DNTKGUARD001RS</basicUdiDi>
    <tradeName>Comfort-Fit Dental Guard</tradeName>
    <deviceName>Dental Guards</deviceName>
    <manufacturerName>DenTek Oral Care Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034440</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10047701000172</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:58:29.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>08711744053581</udiDi>
    <basicUdiDi>506001888DNTKGUARD001RS</basicUdiDi>
    <tradeName>Shiepz™ Anti Tandenknars</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DenTek Oral Care Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034440</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1031050</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:10:09.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>00047701132777</udiDi>
    <basicUdiDi>506001888DNTKGUARD001RS</basicUdiDi>
    <tradeName>Maximum Protection Dental Guard</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DenTek Oral Care Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034440</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01327700101A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:12:12.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>00047701500231</udiDi>
    <basicUdiDi>506001888DNTKREPAIR001ZN</basicUdiDi>
    <tradeName>Essentials Temporary Repair Kit 5+ (1.1g)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DenTek Oral Care Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034440</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0101010203</emdnCode>
    <emdnDescription>TEMPORARY DENTAL CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>050023006DSA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:12:11.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>00047701500323</udiDi>
    <basicUdiDi>506001888DNTKREPAIR001ZN</basicUdiDi>
    <tradeName>Dental First Aid Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DenTek Oral Care Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034440</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0101010203</emdnCode>
    <emdnDescription>TEMPORARY DENTAL CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>050032006DSG</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:12:11.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>00047701502778</udiDi>
    <basicUdiDi>506001888DNTKGUARD001RS</basicUdiDi>
    <tradeName>Maximum Protection Dental Guard</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DenTek Oral Care Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034440</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>n/a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:12:11.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>00047701503218</udiDi>
    <basicUdiDi>506001888DNTKREPAIR001ZN</basicUdiDi>
    <tradeName>Temparin Max Repair Kit 24+ (2 x 2.64g)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DenTek Oral Care Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034440</manufacturerSrn>
    <authorisedRepresentativeName>Elara Pharmaservices Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011852</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0101010203</emdnCode>
    <emdnDescription>TEMPORARY DENTAL CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05032100101A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:12:11.875Z</lastUpdated>
  </row>
</eudamedExport>