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    <manufacturerName>Insulet Corporation</manufacturerName>
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    <reference>18916-5N</reference>
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    <tradeName>Omnipod Insulin Management System</tradeName>
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    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:05:58.982Z</lastUpdated>
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    <udiDi>20385081120125</udiDi>
    <basicUdiDi>B-20385081120125</basicUdiDi>
    <tradeName>Omnipod Insulin Management System</tradeName>
    <deviceName>SKT-ITT400</deviceName>
    <manufacturerName>Insulet Corporation</manufacturerName>
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    <emdnDescription>PORTABLE INSULIN MICROINFUSORS WITH HANDHELD GLUCOSE METER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18916-5K</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:05:58.179Z</lastUpdated>
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    <tradeName>Omnipod Insulin Management System</tradeName>
    <deviceName>EROS Starter Kit</deviceName>
    <manufacturerName>Insulet Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000007948</manufacturerSrn>
    <authorisedRepresentativeName>Insulet Netherlands B.V.</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>Z120402160103</emdnCode>
    <emdnDescription>PORTABLE INSULIN MICROINFUSORS CONNECTABLE TO CONTINUOUS GLUCOSE MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NLT450</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:05:57.387Z</lastUpdated>
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    <udiDi>20385081120095</udiDi>
    <basicUdiDi>B-20385081120095</basicUdiDi>
    <tradeName>Omnipod Insulin Management System</tradeName>
    <deviceName>SKT-DET450</deviceName>
    <manufacturerName>Insulet Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000007948</manufacturerSrn>
    <authorisedRepresentativeName>Insulet Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002337</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>PORTABLE INSULIN MICROINFUSORS WITH HANDHELD GLUCOSE METER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18916-5F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:05:56.582Z</lastUpdated>
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    <udiDi>20385081120033</udiDi>
    <basicUdiDi>B-20385081120033</basicUdiDi>
    <tradeName>Omnipod Insulin Management System</tradeName>
    <deviceName>Omnipod Insulin Management System</deviceName>
    <manufacturerName>Insulet Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000007948</manufacturerSrn>
    <authorisedRepresentativeName>Insulet Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002337</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120402160101</emdnCode>
    <emdnDescription>PORTABLE INSULIN MICROINFUSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZXP425</reference>
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    <lastUpdated>2026-07-30T15:05:52.838Z</lastUpdated>
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    <udiDi>20385081120088</udiDi>
    <basicUdiDi>B-20385081120088</basicUdiDi>
    <tradeName>Omnipod Insulin Management System</tradeName>
    <deviceName>SKT-DET400</deviceName>
    <manufacturerName>Insulet Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000007948</manufacturerSrn>
    <authorisedRepresentativeName>Insulet Netherlands B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>PORTABLE INSULIN MICROINFUSORS WITH HANDHELD GLUCOSE METER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18916-5E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:05:51.943Z</lastUpdated>
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  <row>
    <udiDi>20385081120071</udiDi>
    <basicUdiDi>B-20385081120071</basicUdiDi>
    <tradeName>Omnipod Insulin Management System</tradeName>
    <deviceName>SKT-FRT400</deviceName>
    <manufacturerName>Insulet Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000007948</manufacturerSrn>
    <authorisedRepresentativeName>Insulet Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002337</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120402160102</emdnCode>
    <emdnDescription>PORTABLE INSULIN MICROINFUSORS WITH HANDHELD GLUCOSE METER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18916-5D</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:05:51.885Z</lastUpdated>
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    <udiDi>00810007530901</udiDi>
    <basicUdiDi>081000753TIP9V</basicUdiDi>
    <tradeName>HydraFacial</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hydrafacial, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000004431</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12040299</emdnCode>
    <emdnDescription>GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>74111</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:01:50.053Z</lastUpdated>
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    <basicUdiDi>081000753TIP9V</basicUdiDi>
    <tradeName>HydraFacial</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hydrafacial, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000004431</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>74112</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:01:50.035Z</lastUpdated>
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    <basicUdiDi>081000753TIP9V</basicUdiDi>
    <tradeName>HydraFacial</tradeName>
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    <manufacturerName>Hydrafacial, LLC</manufacturerName>
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    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>74114</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:01:50.009Z</lastUpdated>
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    <basicUdiDi>081000753TIP9V</basicUdiDi>
    <tradeName>HydraFacial</tradeName>
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    <manufacturerName>Hydrafacial, LLC</manufacturerName>
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    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>74275</reference>
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    <tradeName>HydraFacial</tradeName>
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    <manufacturerName>Hydrafacial, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000004431</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>74462</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:01:49.956Z</lastUpdated>
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    <basicUdiDi>081000753TIP9V</basicUdiDi>
    <tradeName>HydraFacial</tradeName>
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    <manufacturerName>Hydrafacial, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000004431</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
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    <reference>7400000</reference>
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    <lastUpdated>2026-07-28T09:01:49.927Z</lastUpdated>
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    <tradeName>HydraFacial</tradeName>
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    <reference>7000131</reference>
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    <lastUpdated>2026-07-28T09:01:49.804Z</lastUpdated>
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    <tradeName>HydraFacial</tradeName>
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    <tradeName>HydraFacial</tradeName>
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    <lastUpdated>2026-07-28T09:01:49.701Z</lastUpdated>
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