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<eudamedExport entity="devices">
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    <basicUdiDi>B-10385081120159</basicUdiDi>
    <tradeName>Omnipod Insulin Management System</tradeName>
    <deviceName>PDM-ATT400</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>18900-5S</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:20:13.900Z</lastUpdated>
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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>
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  <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>
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    <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>08906033940004</udiDi>
    <basicUdiDi>B-08906033940004</basicUdiDi>
    <tradeName>08906033940004</tradeName>
    <deviceName>Infant Thermoregulation System</deviceName>
    <manufacturerName>Phoenix Medical Systems Pvt. Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000022931</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040208</emdnCode>
    <emdnDescription>BODY THERMOREGULATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7.2.3-48</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:54:24.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809578390498</udiDi>
    <basicUdiDi>B-08809578390498</basicUdiDi>
    <tradeName>DVORA</tradeName>
    <deviceName>Phototherapy Unit</deviceName>
    <manufacturerName>IDS LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000018259</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040202</emdnCode>
    <emdnDescription>PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IDS-UM-0732A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:16:11.603Z</lastUpdated>
  </row>
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    <udiDi>08809578390481</udiDi>
    <basicUdiDi>B-08809578390481</basicUdiDi>
    <tradeName>ESTHER</tradeName>
    <deviceName>Phototherapy Unit</deviceName>
    <manufacturerName>IDS LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000018259</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040202</emdnCode>
    <emdnDescription>PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IDS-UM-0732</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:16:09.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809578390474</udiDi>
    <basicUdiDi>B-08809578390474</basicUdiDi>
    <tradeName>SOLAXEL</tradeName>
    <deviceName>Phototherapy Unit</deviceName>
    <manufacturerName>IDS LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000018259</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040202</emdnCode>
    <emdnDescription>PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IDS-UM-0722A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:16:07.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809578390030</udiDi>
    <basicUdiDi>B-08809578390030</basicUdiDi>
    <tradeName>SHINY</tradeName>
    <deviceName>Phototherapy Unit</deviceName>
    <manufacturerName>IDS LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000018259</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040202</emdnCode>
    <emdnDescription>PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IDS-UM-0722</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:14:43.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800081500039</udiDi>
    <basicUdiDi>B-08800081500039</basicUdiDi>
    <tradeName>08800081500039</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NSON</manufacturerName>
    <manufacturerSrn>KR-MF-000039111</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040202</emdnCode>
    <emdnDescription>PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HVEL00-MD01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:23:19.704Z</lastUpdated>
  </row>
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    <udiDi>08800077100045</udiDi>
    <basicUdiDi>B-08800077100045</basicUdiDi>
    <tradeName>SMARTLUX MINI</tradeName>
    <deviceName>Phototherapy Unit</deviceName>
    <manufacturerName>MEDMIX Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000016622</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040202</emdnCode>
    <emdnDescription>PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMARTLUX MINI</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:22:45.883Z</lastUpdated>
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    <udiDi>08800042100308</udiDi>
    <basicUdiDi>B-08800042100308</basicUdiDi>
    <tradeName>REX-LIGHT</tradeName>
    <deviceName>Phototherapy Unit</deviceName>
    <manufacturerName>AMI INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000017522</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040202</emdnCode>
    <emdnDescription>PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMI-CL-0711</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:26:41.522Z</lastUpdated>
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    <udiDi>08800042100247</udiDi>
    <basicUdiDi>B-08800042100247</basicUdiDi>
    <tradeName>SOLRAY</tradeName>
    <deviceName>Phototherapy Unit</deviceName>
    <manufacturerName>AMI INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000017522</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040202</emdnCode>
    <emdnDescription>PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMI-CL-0711</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:26:17.463Z</lastUpdated>
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    <udiDi>08800031600079</udiDi>
    <basicUdiDi>B-08800031600079</basicUdiDi>
    <tradeName>CAREVEAM</tradeName>
    <deviceName>Phototherapy system</deviceName>
    <manufacturerName>Lameditech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007869</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040202</emdnCode>
    <emdnDescription>PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EX-3000</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:06:40.576Z</lastUpdated>
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    <udiDi>08800016900668</udiDi>
    <basicUdiDi>B-08800016900668</basicUdiDi>
    <tradeName>AQUAPURE</tradeName>
    <deviceName>Microdermabrasion System</deviceName>
    <manufacturerName>CLASSYS</manufacturerName>
    <manufacturerSrn>KR-MF-000010116</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040299</emdnCode>
    <emdnDescription>GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQ1-M100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:57:36.853Z</lastUpdated>
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