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<eudamedExport entity="devices">
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    <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></emdnCode>
    <emdnDescription>MEDICAL USE FACE MASKS, TYPE II AND IIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFAS/ALP/HX3</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:14:30.158Z</lastUpdated>
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    <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></emdnCode>
    <emdnDescription>MEDICAL USE FACE MASKS, TYPE II AND IIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASRHX200AF</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:14:29.461Z</lastUpdated>
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  <row>
    <udiDi>05060149200391</udiDi>
    <basicUdiDi>5060149204SKYUTAHM2</basicUdiDi>
    <tradeName>SKYTEC</tradeName>
    <deviceName>Skytec Utah Nitrile Disposable Gloves</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></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SKYUTAH2</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:06:37.239Z</lastUpdated>
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  <row>
    <udiDi>05060149205938</udiDi>
    <basicUdiDi>5060149205SKYTEALKB</basicUdiDi>
    <tradeName>SKYTEC</tradeName>
    <deviceName>Skytec Teal Nitrile Disposable Gloves</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></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SKYTEAL1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:06:35.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060149204870</udiDi>
    <basicUdiDi>5060149204SKYIRISKJ</basicUdiDi>
    <tradeName>SKYTEC</tradeName>
    <deviceName>Skytec Iris Nitrile Disposable Gloves</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></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SKYIRIS1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:06:34.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056739411155</udiDi>
    <basicUdiDi>5056739411KeepsafeHB</basicUdiDi>
    <tradeName>05056739411155</tradeName>
    <deviceName>Keepsafe Nitrile Glove</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>T01020204</emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BNG00001DD</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:00:55.785Z</lastUpdated>
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  <row>
    <udiDi>05056739408148</udiDi>
    <basicUdiDi>5056739408EMG46067</basicUdiDi>
    <tradeName>SKYTEC Elements</tradeName>
    <deviceName>SKYTEC Elements EMG460 Nitrile Disposable Gloves</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>T01020204</emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EMG00460DB</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:00:54.987Z</lastUpdated>
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  <row>
    <udiDi>05056739402474</udiDi>
    <basicUdiDi>5056739402SKY310BB</basicUdiDi>
    <tradeName>SKYTEC</tradeName>
    <deviceName>Skytec AX310 Blue Disposable Nitrile Gloves</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>T01020204</emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SKG00310DD</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:00:54.182Z</lastUpdated>
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  <row>
    <udiDi>05056739400739</udiDi>
    <basicUdiDi>5056739400SKY510AK</basicUdiDi>
    <tradeName>SKYTEC</tradeName>
    <deviceName>Skytec TX510 Blue Nitrile Disposable Gloves</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>T01020204</emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SKG00510DB</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:00:53.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056739400456</udiDi>
    <basicUdiDi>5056739400HAK450XQ</basicUdiDi>
    <tradeName>HAIKA</tradeName>
    <deviceName>HAIKA VX450 Vinyl Disposable Gloves</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>T01020201</emdnCode>
    <emdnDescription>VINYL EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAK4500</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:00:52.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060431750504</udiDi>
    <basicUdiDi>5060431750PUR335XE</basicUdiDi>
    <tradeName>HAIKA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VINYL EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PUR3351</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:22.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060431750511</udiDi>
    <basicUdiDi>5060431750PUR335XE</basicUdiDi>
    <tradeName>HAIKA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PUR3352</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:22.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060431750528</udiDi>
    <basicUdiDi>5060431750PUR335XE</basicUdiDi>
    <tradeName>HAIKA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PUR3353</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:22.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060431750535</udiDi>
    <basicUdiDi>5060431750PUR335XE</basicUdiDi>
    <tradeName>HAIKA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PUR3354</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:22.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060431751211</udiDi>
    <basicUdiDi>5060149204SKYUTAHM2</basicUdiDi>
    <tradeName>SKYTEC</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SKYUTAH1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:22.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060431751488</udiDi>
    <basicUdiDi>5060149205SKYTEALKB</basicUdiDi>
    <tradeName>SKYTEC</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SKYTEAL0</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:22.459Z</lastUpdated>
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    <udiDi>05060431754984</udiDi>
    <basicUdiDi>5060431754HAK16NG</basicUdiDi>
    <tradeName>HAIKA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAK0161</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:22.426Z</lastUpdated>
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    <udiDi>05060431754991</udiDi>
    <basicUdiDi>5060431754HAK16NG</basicUdiDi>
    <tradeName>HAIKA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAK0162</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:22.408Z</lastUpdated>
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    <udiDi>05060431755004</udiDi>
    <basicUdiDi>5060431754HAK16NG</basicUdiDi>
    <tradeName>HAIKA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAK0163</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:22.389Z</lastUpdated>
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    <udiDi>05060431755011</udiDi>
    <basicUdiDi>5060431754HAK16NG</basicUdiDi>
    <tradeName>HAIKA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAK0164</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:22.362Z</lastUpdated>
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