<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05060465560537</udiDi>
    <basicUdiDi>506046556140-10B9</basicUdiDi>
    <tradeName>05060465560537</tradeName>
    <deviceName>Silicone Boyle Davis Gag Cover (Non Sterile)</deviceName>
    <manufacturerName>Medasil Surgical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000009549</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>140-1030-1200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:18:12.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060465560520</udiDi>
    <basicUdiDi>506046556140-11BB</basicUdiDi>
    <tradeName>05060465560520</tradeName>
    <deviceName>Sterile Silicone Boyle Davis Gag Covers</deviceName>
    <manufacturerName>Medasil Surgical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000009549</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>140-1130-1200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:18:11.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060465560308</udiDi>
    <basicUdiDi>506046556120-10AK</basicUdiDi>
    <tradeName>05060465560308</tradeName>
    <deviceName>Non Sterile-Silicone Nasal Splints</deviceName>
    <manufacturerName>Medasil Surgical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000009549</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P020203</emdnCode>
    <emdnDescription>NASAL SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>120-1020-2257</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:18:10.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060465560292</udiDi>
    <basicUdiDi>506046556120-11AM</basicUdiDi>
    <tradeName>05060465560292</tradeName>
    <deviceName>Silicone Nasal Splints</deviceName>
    <manufacturerName>Medasil Surgical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000009549</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P020203</emdnCode>
    <emdnDescription>NASAL SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>120-1120-2257</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:18:10.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060465560193</udiDi>
    <basicUdiDi>506046556112-31AW</basicUdiDi>
    <tradeName>05060465560193</tradeName>
    <deviceName>Zoellner Suction Tip</deviceName>
    <manufacturerName>Medasil Surgical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000009549</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112-3150-1018</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:18:09.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060465560063</udiDi>
    <basicUdiDi>506046556101-10A4</basicUdiDi>
    <tradeName>05060465560063</tradeName>
    <deviceName>Silicone Bite Guard Blue- Non-Sterile.</deviceName>
    <manufacturerName>Medasil Surgical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000009549</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0306</emdnCode>
    <emdnDescription>PATIENT PROTECTION DEVICES DURING CLINICAL PROCEDURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-1020-1200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:18:08.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060465560056</udiDi>
    <basicUdiDi>506046556101-11A6</basicUdiDi>
    <tradeName>05060465560056</tradeName>
    <deviceName>Sterile Silicone Bite Guards</deviceName>
    <manufacturerName>Medasil Surgical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000009549</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0306</emdnCode>
    <emdnDescription>PATIENT PROTECTION DEVICES DURING CLINICAL PROCEDURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-1120-1200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:18:07.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060413444322</udiDi>
    <basicUdiDi>506041344QE6023</basicUdiDi>
    <tradeName>Qe606030LC</tradeName>
    <deviceName>Surgical Luminaire</deviceName>
    <manufacturerName>Brandon Medical Company Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000005501</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Qe606030LC</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:13:53.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060293171271</udiDi>
    <basicUdiDi>5060293171271TN</basicUdiDi>
    <tradeName>PUFFClicker</tradeName>
    <deviceName>PUFFClicker Inhaler Dose Counter Accessory for Aerosphere Trixeo / Bevespi pMDI</deviceName>
    <manufacturerName>Aseptika Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000037607</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P060/P175</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:12:49.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060293171264</udiDi>
    <basicUdiDi>5060293171264TR</basicUdiDi>
    <tradeName>PUFFClicker</tradeName>
    <deviceName>PUFFClicker3 Inhaler Dose Counter Accessory for Accuhaler Seretide / Flixotide / Ventolin / Serevent DPI</deviceName>
    <manufacturerName>Aseptika Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000037607</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P163</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:12:48.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060293171257</udiDi>
    <basicUdiDi>5060293171257TU</basicUdiDi>
    <tradeName>PUFFClicker</tradeName>
    <deviceName>PUFFClicker3 Inhaler Dose Counter Accessory for Ellipta Relvar / Anoro / Incuse / Trelegy DPI</deviceName>
    <manufacturerName>Aseptika Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000037607</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P162</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:12:47.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060293171240</udiDi>
    <basicUdiDi>5060293171240TB</basicUdiDi>
    <tradeName>PUFFClicker</tradeName>
    <deviceName>PUFFClicker3 Inhaler Dose Counter Accessory for Novolizer Budelin / Elkira / Duakli / Salbulin  DPI</deviceName>
    <manufacturerName>Aseptika Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000037607</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P161</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:12:46.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060293171233</udiDi>
    <basicUdiDi>5060293171233TE</basicUdiDi>
    <tradeName>PUFFClicker</tradeName>
    <deviceName>PUFFClicker3 Inhaler Dose Counter Accessory for Turbohaler Symbicort / Oxis / Pulmicort / Bricanyl DPI</deviceName>
    <manufacturerName>Aseptika Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000037607</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P160</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:12:45.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060293171226</udiDi>
    <basicUdiDi>5060293171226TH</basicUdiDi>
    <tradeName>PUFFClicker</tradeName>
    <deviceName>PUFFClicker3 Inhaler Dose Counter Accessory for Spriomax DuoResp DPI</deviceName>
    <manufacturerName>Aseptika Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000037607</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P159</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:12:45.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060293171219</udiDi>
    <basicUdiDi>5060293171219TL</basicUdiDi>
    <tradeName>PUFFClicker</tradeName>
    <deviceName>PUFFClicker3 Inhaler Dose Counter Accessory for WockAIR / AirFluSal Forspiro DPI</deviceName>
    <manufacturerName>Aseptika Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000037607</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P158</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:12:44.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060293171202</udiDi>
    <basicUdiDi>5060293171202T3</basicUdiDi>
    <tradeName>PUFFClicker</tradeName>
    <deviceName>PUFFClicker3 Inhaler Dose Counter Accessory for Easyhaler Formoterol / Beclometasone / Salbutamol / Fobumix / Fusacomb / Budesonide DPI</deviceName>
    <manufacturerName>Aseptika Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000037607</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P157</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:12:43.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060293171196</udiDi>
    <basicUdiDi>5060293171196TZ</basicUdiDi>
    <tradeName>PUFFClicker</tradeName>
    <deviceName>PUFFClicker3 Inhaler Dose Counter Accessory for NEXThaler Fostair / Trimbow DPI</deviceName>
    <manufacturerName>Aseptika Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000037607</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P156</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:12:42.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060293171189</udiDi>
    <basicUdiDi>5060293171189U4</basicUdiDi>
    <tradeName>PUFFClicker</tradeName>
    <deviceName>PUFFClicker Inhaler Dose Counter Accessory for Easi-Breathe Qvar / IVAX Salamol pMDI</deviceName>
    <manufacturerName>Aseptika Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000037607</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P155</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:12:41.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060293171172</udiDi>
    <basicUdiDi>5060293171172TK</basicUdiDi>
    <tradeName>PUFFClicker</tradeName>
    <deviceName>PUFFClicker Inhaler Dose Counter Accessory for Atrovent pMDI</deviceName>
    <manufacturerName>Aseptika Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000037607</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P154/P176</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:12:41.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060293171165</udiDi>
    <basicUdiDi>5060293171165TN</basicUdiDi>
    <tradeName>PUFFClicker</tradeName>
    <deviceName>PUFFClicker Inhaler Dose Counter Accessory for Sereflo / AirFluSa / Luforbec pMDI</deviceName>
    <manufacturerName>Aseptika Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000037607</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P153/P174</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:12:40.372Z</lastUpdated>
  </row>
</eudamedExport>