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<eudamedExport entity="devices">
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    <udiDi>05060855887473</udiDi>
    <basicUdiDi>50608558874733P</basicUdiDi>
    <tradeName>SteriPack</tradeName>
    <deviceName>Sanity SPL-2</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>Sanity SPL-2</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:55:56.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060855887442</udiDi>
    <basicUdiDi>50608558874353F</basicUdiDi>
    <tradeName>05060855887442</tradeName>
    <deviceName>Sanity SP-2</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>Sanity SP-2</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:55:56.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060855887435</udiDi>
    <basicUdiDi>506085587435CH</basicUdiDi>
    <tradeName>SteriPack</tradeName>
    <deviceName>Sanity SP-2</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>Sanity SP-2</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:55:54.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060855887183</udiDi>
    <basicUdiDi>50608558876020TF</basicUdiDi>
    <tradeName>ALPHA</tradeName>
    <deviceName>6020 Cup Mask 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>ASR60200AZ</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:55:52.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060855887015</udiDi>
    <basicUdiDi>5060855887HXCL28H</basicUdiDi>
    <tradeName>ALPHA</tradeName>
    <deviceName>HXCL-2 Clear Panel 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>ASRHXC200AH</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:55:50.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060855886995</udiDi>
    <basicUdiDi>5060855886HXCL386</basicUdiDi>
    <tradeName>ALPHA</tradeName>
    <deviceName>HXCL-3 Clear Panel 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>ASRHXC300AH</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:55:50.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060855885578</udiDi>
    <basicUdiDi>5060855885HXC26A</basicUdiDi>
    <tradeName>ALPHA</tradeName>
    <deviceName>HXC-2 Clear Panel 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>ASRHXC200AF</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:55:40.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060855885509</udiDi>
    <basicUdiDi>5060855885HXC36C</basicUdiDi>
    <tradeName>ALPHA</tradeName>
    <deviceName>HXC-3 Clear Panel 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>ASRHXC300AF</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:55:37.752Z</lastUpdated>
  </row>
  <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>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>04897146981890</udiDi>
    <basicUdiDi>489714698PRCLFACEMASKXL</basicUdiDi>
    <tradeName>F. Bosch Non-Woven 3ply Earloop Facemask, Black</tradeName>
    <deviceName>FACEMASK</deviceName>
    <manufacturerName>F. Bosch International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000029001</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</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>PRCL-1071</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:21:45.856Z</lastUpdated>
  </row>
</eudamedExport>