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    <deviceName></deviceName>
    <manufacturerName>Isol8 Healthcare Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000012420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS8E03</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:57:52.743Z</lastUpdated>
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    <basicUdiDi>0539154127IS8SMXG</basicUdiDi>
    <tradeName>ISOL/8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Isol8 Healthcare Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000012420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MEDICAL USE FACE MASKS, TYPE II AND IIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS8RM01S</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:57:52.713Z</lastUpdated>
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    <tradeName>ISOL/8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Isol8 Healthcare Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000012420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS8E04</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:57:52.681Z</lastUpdated>
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    <udiDi>05391541270058</udiDi>
    <basicUdiDi>B-05391541270058</basicUdiDi>
    <tradeName>ISOL/8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Isol8 Healthcare Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000012420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS8E05</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:57:52.663Z</lastUpdated>
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    <udiDi>05391541270065</udiDi>
    <basicUdiDi>B-05391541270065</basicUdiDi>
    <tradeName>ISOL/8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Isol8 Healthcare Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000012420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS8E06</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:57:52.646Z</lastUpdated>
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    <udiDi>05391541270072</udiDi>
    <basicUdiDi>B-05391541270072</basicUdiDi>
    <tradeName>ISOL/8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Isol8 Healthcare Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000012420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS8E07</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:57:52.624Z</lastUpdated>
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    <udiDi>05391541270089</udiDi>
    <basicUdiDi>B-05391541270089</basicUdiDi>
    <tradeName>ISOL/8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Isol8 Healthcare Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000012420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS8E08</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:57:52.605Z</lastUpdated>
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    <udiDi>05391541270096</udiDi>
    <basicUdiDi>B-05391541270096</basicUdiDi>
    <tradeName>ISOL/8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Isol8 Healthcare Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000012420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS8E09</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:57:52.578Z</lastUpdated>
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    <udiDi>05391541270102</udiDi>
    <basicUdiDi>B-05391541270102</basicUdiDi>
    <tradeName>ISOL/8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Isol8 Healthcare Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000012420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS8E10</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:57:52.550Z</lastUpdated>
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    <udiDi>05391541270119</udiDi>
    <basicUdiDi>B-05391541270119</basicUdiDi>
    <tradeName>ISOL/8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Isol8 Healthcare Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000012420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS8E11</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:57:52.523Z</lastUpdated>
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    <udiDi>05391541270126</udiDi>
    <basicUdiDi>B-05391541270126</basicUdiDi>
    <tradeName>ISOL/8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Isol8 Healthcare Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000012420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS8E12</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:57:52.494Z</lastUpdated>
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    <udiDi>05391541270133</udiDi>
    <basicUdiDi>B-05391541270133</basicUdiDi>
    <tradeName>ISOL/8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Isol8 Healthcare Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000012420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS8E13</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:57:52.457Z</lastUpdated>
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    <udiDi>05391541270140</udiDi>
    <basicUdiDi>B-05391541270140</basicUdiDi>
    <tradeName>ISOL/8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Isol8 Healthcare Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000012420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS8E14</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:57:52.430Z</lastUpdated>
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    <udiDi>05391541270157</udiDi>
    <basicUdiDi>B-05391541270157</basicUdiDi>
    <tradeName>ISOL/8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Isol8 Healthcare Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000012420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS8P01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:57:52.397Z</lastUpdated>
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    <udiDi>05391541270164</udiDi>
    <basicUdiDi>B-05391541270164</basicUdiDi>
    <tradeName>ISOL/8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Isol8 Healthcare Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000012420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS8P02</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:57:52.371Z</lastUpdated>
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    <udiDi>05391541270171</udiDi>
    <basicUdiDi>B-05391541270171</basicUdiDi>
    <tradeName>ISOL/8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Isol8 Healthcare Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000012420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS8P03</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:57:52.335Z</lastUpdated>
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    <udiDi>05391541270188</udiDi>
    <basicUdiDi>B-05391541270188</basicUdiDi>
    <tradeName>ISOL/8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Isol8 Healthcare Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000012420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS8P04</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:57:52.315Z</lastUpdated>
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    <udiDi>05391541270195</udiDi>
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    <tradeName>ISOL/8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Isol8 Healthcare Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000012420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS8P05</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:57:52.290Z</lastUpdated>
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    <tradeName>ISOL/8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Isol8 Healthcare Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000012420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS8P06</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:57:52.262Z</lastUpdated>
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    <tradeName>ISOL/8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Isol8 Healthcare Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000012420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS8P07</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:57:52.238Z</lastUpdated>
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