<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05060722250461</udiDi>
    <basicUdiDi>B-05060722250461</basicUdiDi>
    <tradeName>Amity PAA 5 System - Part B</tradeName>
    <deviceName>Amity PAA 5 System - Part B</deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>D050101</emdnCode>
    <emdnDescription>PERACETIC AND ACETIC ACID WITH HYDROGEN PEROXIDE FOR THE DISINFECTION OF MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J83C</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:26:11.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060722251796</udiDi>
    <basicUdiDi>506072225AAA0005JS</basicUdiDi>
    <tradeName>Scope-Pro 2 Tube Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011380</emdnCode>
    <emdnDescription>CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q87TK</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:30:53.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060722251789</udiDi>
    <basicUdiDi>506072225AAA0025JY</basicUdiDi>
    <tradeName>SCOPE-Flush</tradeName>
    <deviceName>SCOPE-Flush</deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011301</emdnCode>
    <emdnDescription>CLEANING AND DISINFECTION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q88</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:30:52.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060722251703</udiDi>
    <basicUdiDi>506072225AAA0013JR</basicUdiDi>
    <tradeName>Surgiglide Spray (aerosol)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9007</emdnCode>
    <emdnDescription>STERILE INSTRUMENT LUBRICANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J92C</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:30:51.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060722251192</udiDi>
    <basicUdiDi>506072225AAA0016JX</basicUdiDi>
    <tradeName>Viruzyme</tradeName>
    <deviceName>VZF</deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J60A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:30:50.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060722250782</udiDi>
    <basicUdiDi>506072225AAA0014JT</basicUdiDi>
    <tradeName>Virudet+</tradeName>
    <deviceName>VDF</deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>D0899</emdnCode>
    <emdnDescription>DETERGENTS FOR MEDICAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J70A</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:30:50.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060722253462</udiDi>
    <basicUdiDi>506072225AAA0016JX</basicUdiDi>
    <tradeName>Viruzyme 3N</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J100B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:44:57.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060722253431</udiDi>
    <basicUdiDi>506072225AAA0016JX</basicUdiDi>
    <tradeName>Viruzyme 3N</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J100D</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:44:57.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060722253479</udiDi>
    <basicUdiDi>506072225AAA0016JX</basicUdiDi>
    <tradeName>Viruzyme 3N</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J100E</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:44:57.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060722253486</udiDi>
    <basicUdiDi>506072225AAA0016JX</basicUdiDi>
    <tradeName>Viruzyme 5N</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J101D</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:49:58.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060722253493</udiDi>
    <basicUdiDi>506072225AAA0016JX</basicUdiDi>
    <tradeName>Viruzyme 5N</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J101E</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:49:58.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060722253509</udiDi>
    <basicUdiDi>506072225AAA0013JR</basicUdiDi>
    <tradeName>Surgiglide Eco</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STERILE INSTRUMENT LUBRICANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J102D</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:49:58.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060722253516</udiDi>
    <basicUdiDi>506072225AAA0016JX</basicUdiDi>
    <tradeName>Olie Medical Performance PreClean+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OLI-J98TPP12</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:49:58.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060722253523</udiDi>
    <basicUdiDi>506072225AAA0016JX</basicUdiDi>
    <tradeName>Olie Medical Performance Enzymatic 5+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OLI-J69EPB200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:49:58.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060722253530</udiDi>
    <basicUdiDi>506072225AAA0014JT</basicUdiDi>
    <tradeName>Olie Medical Performance Alkaline</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DETERGENTS FOR MEDICAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OLI-J77AB200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:49:58.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060722253547</udiDi>
    <basicUdiDi>506072225AAA0016JX</basicUdiDi>
    <tradeName>Olie Medical Performance Enzymatic 5N</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OLI-J97ABC200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:49:58.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060722253554</udiDi>
    <basicUdiDi>506072225AAA0013JR</basicUdiDi>
    <tradeName>Surgiglide Spray (aerosol)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STERILE INSTRUMENT LUBRICANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J92D</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:49:58.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060722253455</udiDi>
    <basicUdiDi>506072225AAA0013JR</basicUdiDi>
    <tradeName>Surgiglide Eco</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V9007</emdnCode>
    <emdnDescription>STERILE INSTRUMENT LUBRICANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J102B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:59:41.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060722253448</udiDi>
    <basicUdiDi>506072225AAA0016JX</basicUdiDi>
    <tradeName>Viruzyme 5N</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J101B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:59:39.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060722253424</udiDi>
    <basicUdiDi>506072225AAA0016JX</basicUdiDi>
    <tradeName>PreFoam Enzyme</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amity Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000023321</manufacturerSrn>
    <authorisedRepresentativeName>Amity Healthcare EU Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011613</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J98TP</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:59:36.948Z</lastUpdated>
  </row>
</eudamedExport>