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<eudamedExport entity="devices">
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    <udiDi>10385081120142</udiDi>
    <basicUdiDi>B-10385081120142</basicUdiDi>
    <tradeName>Omnipod Insulin Management System</tradeName>
    <deviceName>PDM-SVT450</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>18900-5N</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:20:09.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>10385081120135</udiDi>
    <basicUdiDi>B-10385081120135</basicUdiDi>
    <tradeName>Omnipod Insulin Management System</tradeName>
    <deviceName>PDM-NOT450</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>18900-5M</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:20:09.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>10385081120128</udiDi>
    <basicUdiDi>B-10385081120128</basicUdiDi>
    <tradeName>Omnipod Insulin Management System</tradeName>
    <deviceName>PDM-ITT400</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>18900-5K</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:20:08.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>10385081120111</udiDi>
    <basicUdiDi>B-10385081120111</basicUdiDi>
    <tradeName>Omnipod Insulin Management System</tradeName>
    <deviceName>EROS PDM</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>NLT450</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:20:07.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>10385081120098</udiDi>
    <basicUdiDi>B-10385081120098</basicUdiDi>
    <tradeName>Omnipod Insulin Management System</tradeName>
    <deviceName>PDM-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>
    <emdnCode>Z120402160101</emdnCode>
    <emdnDescription>PORTABLE INSULIN MICROINFUSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18900-5F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:20:03.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>10385081120081</udiDi>
    <basicUdiDi>B-10385081120081</basicUdiDi>
    <tradeName>Omnipod Insulin Management System</tradeName>
    <deviceName>PDM-DET400</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>18900-5E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:20:02.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>10385081120074</udiDi>
    <basicUdiDi>B-10385081120074</basicUdiDi>
    <tradeName>Omnipod Insulin Management System</tradeName>
    <deviceName>PDM-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>Z120402160101</emdnCode>
    <emdnDescription>PORTABLE INSULIN MICROINFUSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PDM-FRT400</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:20:01.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>10385081120036</udiDi>
    <basicUdiDi>B-10385081120036</basicUdiDi>
    <tradeName>Omnipod Insulin Management System</tradeName>
    <deviceName>EROS Single Pod</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>ZXP420</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:20:01.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971123681510</udiDi>
    <basicUdiDi>B-06971123681510</basicUdiDi>
    <tradeName>Touchcare System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medtrum Technologies Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001942</manufacturerSrn>
    <authorisedRepresentativeName>Medtrum B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000595</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120402160101</emdnCode>
    <emdnDescription>PORTABLE INSULIN MICROINFUSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SY-301</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:10:19.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971123681497</udiDi>
    <basicUdiDi>B-06971123681497</basicUdiDi>
    <tradeName>Pump Base</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medtrum Technologies Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001942</manufacturerSrn>
    <authorisedRepresentativeName>Medtrum B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000595</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120402160101</emdnCode>
    <emdnDescription>PORTABLE INSULIN MICROINFUSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD8301</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:10:17.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971123681091</udiDi>
    <basicUdiDi>B-06971123681091</basicUdiDi>
    <tradeName>Pump Base</tradeName>
    <deviceName>Pump Base</deviceName>
    <manufacturerName>Medtrum Technologies Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001942</manufacturerSrn>
    <authorisedRepresentativeName>Medtrum B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000595</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120402160101</emdnCode>
    <emdnDescription>PORTABLE INSULIN MICROINFUSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD8201</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:10:08.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971123680957</udiDi>
    <basicUdiDi>B-06971123680957</basicUdiDi>
    <tradeName>Pump Base</tradeName>
    <deviceName>Pump Base</deviceName>
    <manufacturerName>Medtrum Technologies Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001942</manufacturerSrn>
    <authorisedRepresentativeName>Medtrum B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000595</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120402160101</emdnCode>
    <emdnDescription>PORTABLE INSULIN MICROINFUSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD0201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:10:06.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971123680919</udiDi>
    <basicUdiDi>B-06971123680919</basicUdiDi>
    <tradeName>A8 TouchCare System</tradeName>
    <deviceName>Insulin Management System</deviceName>
    <manufacturerName>Medtrum Technologies Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001942</manufacturerSrn>
    <authorisedRepresentativeName>Medtrum B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000595</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120402160101</emdnCode>
    <emdnDescription>PORTABLE INSULIN MICROINFUSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SY-201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:10:03.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971123680636</udiDi>
    <basicUdiDi>B-06971123680636</basicUdiDi>
    <tradeName>A7+ TouchCare System</tradeName>
    <deviceName>Insulin Management System</deviceName>
    <manufacturerName>Medtrum Technologies Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001942</manufacturerSrn>
    <authorisedRepresentativeName>Medtrum B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000595</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120402160101</emdnCode>
    <emdnDescription>PORTABLE INSULIN MICROINFUSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SY-018</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:09:50.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971123680643</udiDi>
    <basicUdiDi>B-06971123680643</basicUdiDi>
    <tradeName>A7+ TouchCare System</tradeName>
    <deviceName>Insulin Management Sytem</deviceName>
    <manufacturerName>Medtrum Technologies Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001942</manufacturerSrn>
    <authorisedRepresentativeName>Medtrum B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000595</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120402160101</emdnCode>
    <emdnDescription>PORTABLE INSULIN MICROINFUSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SY-018</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:09:49.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971123680605</udiDi>
    <basicUdiDi>B-06971123680605</basicUdiDi>
    <tradeName>Pump Base</tradeName>
    <deviceName>Pump Base</deviceName>
    <manufacturerName>Medtrum Technologies Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001942</manufacturerSrn>
    <authorisedRepresentativeName>Medtrum B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000595</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120402160101</emdnCode>
    <emdnDescription>PORTABLE INSULIN MICROINFUSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JN-022</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:09:48.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971123680629</udiDi>
    <basicUdiDi>B-06971123680629</basicUdiDi>
    <tradeName>A7+ TouchCare System</tradeName>
    <deviceName>Insulin Management System</deviceName>
    <manufacturerName>Medtrum Technologies Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001942</manufacturerSrn>
    <authorisedRepresentativeName>Medtrum B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000595</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120402160101</emdnCode>
    <emdnDescription>PORTABLE INSULIN MICROINFUSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SY-018</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:09:46.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971123680599</udiDi>
    <basicUdiDi>B-06971123680599</basicUdiDi>
    <tradeName>Pump Base</tradeName>
    <deviceName>Pump Base</deviceName>
    <manufacturerName>Medtrum Technologies Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001942</manufacturerSrn>
    <authorisedRepresentativeName>Medtrum B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000595</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120402160101</emdnCode>
    <emdnDescription>PORTABLE INSULIN MICROINFUSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JN-022</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:09:31.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971123680582</udiDi>
    <basicUdiDi>B-06971123680582</basicUdiDi>
    <tradeName>Pump Base</tradeName>
    <deviceName>Pump Base</deviceName>
    <manufacturerName>Medtrum Technologies Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001942</manufacturerSrn>
    <authorisedRepresentativeName>Medtrum B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000595</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120402160101</emdnCode>
    <emdnDescription>PORTABLE INSULIN MICROINFUSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JN-022</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:09:29.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971123680575</udiDi>
    <basicUdiDi>B-06971123680575</basicUdiDi>
    <tradeName>Personal Diabetes Manager</tradeName>
    <deviceName>Personal Diabetes Manager</deviceName>
    <manufacturerName>Medtrum Technologies Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001942</manufacturerSrn>
    <authorisedRepresentativeName>Medtrum B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000595</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120402160101</emdnCode>
    <emdnDescription>PORTABLE INSULIN MICROINFUSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FM-018</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:09:29.133Z</lastUpdated>
  </row>
</eudamedExport>