<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05060855884977</udiDi>
    <basicUdiDi>5060855885ASF249</basicUdiDi>
    <tradeName>ALPHA</tradeName>
    <deviceName>ASF-2 Alpha Fold+ FFP2</deviceName>
    <manufacturerName>Alpha Solway Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000019916</manufacturerSrn>
    <authorisedRepresentativeName>Globus EMEA Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002785</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020604</emdnCode>
    <emdnDescription>MEDICAL USE FACE MASKS, TYPE II AND IIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASRASF200AF</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:55:36.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060855884908</udiDi>
    <basicUdiDi>50608558843530SM</basicUdiDi>
    <tradeName>ALPHA</tradeName>
    <deviceName>3530 Cup Mask FFP3</deviceName>
    <manufacturerName>Alpha Solway Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000019916</manufacturerSrn>
    <authorisedRepresentativeName>Globus EMEA Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002785</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020604</emdnCode>
    <emdnDescription>MEDICAL USE FACE MASKS, TYPE II AND IIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASR35300AZ</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:55:35.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060855885059</udiDi>
    <basicUdiDi>5060855885ASFS25B</basicUdiDi>
    <tradeName>ALPHA</tradeName>
    <deviceName>ASFS-2 Alpha Fold+ S FFP2</deviceName>
    <manufacturerName>Alpha Solway Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000019916</manufacturerSrn>
    <authorisedRepresentativeName>Globus EMEA Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002785</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020604</emdnCode>
    <emdnDescription>MEDICAL USE FACE MASKS, TYPE II AND IIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASRASF200AD</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:55:33.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060855884397</udiDi>
    <basicUdiDi>50608558843973B</basicUdiDi>
    <tradeName>HAIKA</tradeName>
    <deviceName>MXC Transparent Face Mask</deviceName>
    <manufacturerName>Globus (Shetland) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000007384</manufacturerSrn>
    <authorisedRepresentativeName>Globus EMEA Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002785</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020604</emdnCode>
    <emdnDescription>MEDICAL USE FACE MASKS, TYPE II AND IIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAK6000</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:55:15.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060855884199</udiDi>
    <basicUdiDi>5060855884HXL26S</basicUdiDi>
    <tradeName>ALPHA</tradeName>
    <deviceName>HXL-2 Horizontal Fold Flat Large FFP2</deviceName>
    <manufacturerName>Alpha Solway Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000019916</manufacturerSrn>
    <authorisedRepresentativeName>Globus EMEA Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002785</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020604</emdnCode>
    <emdnDescription>MEDICAL USE FACE MASKS, TYPE II AND IIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASRHX200AH</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:55:13.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060855884175</udiDi>
    <basicUdiDi>5060855884HXL36U</basicUdiDi>
    <tradeName>ALPHA</tradeName>
    <deviceName>HXL-3 Horizontal Fold Flat Large FFP3</deviceName>
    <manufacturerName>Alpha Solway Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000019916</manufacturerSrn>
    <authorisedRepresentativeName>Globus EMEA Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002785</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020604</emdnCode>
    <emdnDescription>MEDICAL USE FACE MASKS, TYPE II AND IIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASRHX300AH</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:55:09.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060807410230</udiDi>
    <basicUdiDi>506080741MSM0013T</basicUdiDi>
    <tradeName>FACE GUARD</tradeName>
    <deviceName>Surgical Mask</deviceName>
    <manufacturerName>Global Health and Safety Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000042285</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020604</emdnCode>
    <emdnDescription>MEDICAL USE FACE MASKS, TYPE II AND IIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FGMSM101305</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:54:49.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060414987231</udiDi>
    <basicUdiDi>5060414987HX34A</basicUdiDi>
    <tradeName>ALPHA</tradeName>
    <deviceName>HX-3 Horizontal Fold Flat FFP3</deviceName>
    <manufacturerName>Alpha Solway Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000019916</manufacturerSrn>
    <authorisedRepresentativeName>Globus EMEA Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002785</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020604</emdnCode>
    <emdnDescription>MEDICAL USE FACE MASKS, TYPE II AND IIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFAS/ALP/HX3</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:44:05.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060414987217</udiDi>
    <basicUdiDi>5060414987HX248</basicUdiDi>
    <tradeName>ALPHA</tradeName>
    <deviceName>HX-2 Horizontal Fold Flat FFP2</deviceName>
    <manufacturerName>Alpha Solway Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000019916</manufacturerSrn>
    <authorisedRepresentativeName>Globus EMEA Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002785</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020604</emdnCode>
    <emdnDescription>MEDICAL USE FACE MASKS, TYPE II AND IIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASRHX200AF</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:44:04.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060414987132</udiDi>
    <basicUdiDi>5060414987H3AD</basicUdiDi>
    <tradeName>ALPHA</tradeName>
    <deviceName>H-3 Horizontal Fold Flat FFP3</deviceName>
    <manufacturerName>Alpha Solway Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000019916</manufacturerSrn>
    <authorisedRepresentativeName>Globus EMEA Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002785</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020604</emdnCode>
    <emdnDescription>MEDICAL USE FACE MASKS, TYPE II AND IIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFAS/ALP/H3</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:44:01.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060069360182</udiDi>
    <basicUdiDi>506006936NDPE</basicUdiDi>
    <tradeName>Orthopaedic U-Sheet 2</tradeName>
    <deviceName>Easidrape™ sterile surgical drapes</deviceName>
    <manufacturerName>Full Support Healthcare Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000040654</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020102</emdnCode>
    <emdnDescription>SPECIALISTIC SURGERY DRAPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60433</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:41:01.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060069360175</udiDi>
    <basicUdiDi>506006936NDPE</basicUdiDi>
    <tradeName>Split U-Drape</tradeName>
    <deviceName>Easidrape™ sterile surgical drapes</deviceName>
    <manufacturerName>Full Support Healthcare Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000040654</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020199</emdnCode>
    <emdnDescription>SURGICAL DRAPES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60269</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:31:23.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060069365644</udiDi>
    <basicUdiDi>506006936PPQC</basicUdiDi>
    <tradeName>Universal Set</tradeName>
    <deviceName>Easidrape™ sterile procedure packs</deviceName>
    <manufacturerName>Full Support Healthcare Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000040654</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0202</emdnCode>
    <emdnDescription>SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50401</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:25:52.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060069363626</udiDi>
    <basicUdiDi>506006936CGNK</basicUdiDi>
    <tradeName>Isolation Gown - Universal Size</tradeName>
    <deviceName>Easigown™ cover gowns and isolation gowns (non-sterile)</deviceName>
    <manufacturerName>Full Support Healthcare Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000040654</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0205</emdnCode>
    <emdnDescription>NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40012L</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:25:52.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060069361257</udiDi>
    <basicUdiDi>506006936NGPL</basicUdiDi>
    <tradeName>Surgical Gown - Standard Protection - Blue, Large</tradeName>
    <deviceName>Easigown™ surgical gowns (non-sterile)</deviceName>
    <manufacturerName>Full Support Healthcare Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000040654</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48010</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:25:46.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060069360892</udiDi>
    <basicUdiDi>506006936D4Y</basicUdiDi>
    <tradeName>Laminated Fenestrated Drape 2</tradeName>
    <deviceName>Easidrape™ sterile surgical drapes</deviceName>
    <manufacturerName>Full Support Healthcare Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000040654</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020199</emdnCode>
    <emdnDescription>SURGICAL DRAPES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>58417</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:25:46.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060069360199</udiDi>
    <basicUdiDi>506006936G56</basicUdiDi>
    <tradeName>Surgical Gown, Standard Protection - Blue, X-Large, X-Long</tradeName>
    <deviceName>Easigown™ sterile surgical gowns</deviceName>
    <manufacturerName>Full Support Healthcare Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000040654</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30013</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:25:45.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060069360151</udiDi>
    <basicUdiDi>506006936NDPE</basicUdiDi>
    <tradeName>Laparotomy/Incise Drape</tradeName>
    <deviceName>Easidrape™ sterile surgical drapes</deviceName>
    <manufacturerName>Full Support Healthcare Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000040654</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T02010101</emdnCode>
    <emdnDescription>INCISION DRAPES, WITHOUT ANTIBACTERIAL AGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60262</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:25:44.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>05020581290381</udiDi>
    <basicUdiDi>5020581STE004JS</basicUdiDi>
    <tradeName>05020581290381</tradeName>
    <deviceName>Face Mask</deviceName>
    <manufacturerName>Steroplast Healthcare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000018088</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020604</emdnCode>
    <emdnDescription>MEDICAL USE FACE MASKS, TYPE II AND IIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1816/5</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:52:55.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>05019829009809</udiDi>
    <basicUdiDi>5019829C01nT036G0BBG</basicUdiDi>
    <tradeName>COMFIWEAR ADULT LEGGINGS LARGE 46"-60"</tradeName>
    <deviceName>Elasticated Tubular Bandages and Garments (ComfiGarments)</deviceName>
    <manufacturerName>Vernacare</manufacturerName>
    <manufacturerSrn>GB-MF-000008063</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0299</emdnCode>
    <emdnDescription>PROTECTION DRAPES AND GARMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL22</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:52:34.449Z</lastUpdated>
  </row>
</eudamedExport>