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    <basicUdiDi>10850037993113HC</basicUdiDi>
    <tradeName>10850037993113</tradeName>
    <deviceName>spECTrum Safety Monitor Cable IEC EEG/ECG</deviceName>
    <manufacturerName>MECTA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019538</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109002</emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9010-0011-02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:24:52.895Z</lastUpdated>
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  <row>
    <udiDi>10850037993106</udiDi>
    <basicUdiDi>10850037993106HF</basicUdiDi>
    <tradeName>10850037993106</tradeName>
    <deviceName>spECTrum Safety Monitor Cable DOM EEG/ECG</deviceName>
    <manufacturerName>MECTA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019538</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109002</emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9010-0011-01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:24:52.090Z</lastUpdated>
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  <row>
    <udiDi>10850037993045</udiDi>
    <basicUdiDi>10850037993045HL</basicUdiDi>
    <tradeName>10850037993045</tradeName>
    <deviceName>EEG Safety Leads (Gray)</deviceName>
    <manufacturerName>MECTA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019538</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109002</emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9013-0001-02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:24:51.290Z</lastUpdated>
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  <row>
    <udiDi>10850037993038</udiDi>
    <basicUdiDi>10850037993038HP</basicUdiDi>
    <tradeName>10850037993038</tradeName>
    <deviceName>EMG Safety Leads (Blue)</deviceName>
    <manufacturerName>MECTA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019538</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109002</emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9013-0010</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:24:47.291Z</lastUpdated>
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  <row>
    <udiDi>10850037993021</udiDi>
    <basicUdiDi>10850037993021H6</basicUdiDi>
    <tradeName>10850037993021</tradeName>
    <deviceName>EEG Safety Leads (Brown)</deviceName>
    <manufacturerName>MECTA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019538</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109002</emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9013-0001-01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:24:46.494Z</lastUpdated>
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  <row>
    <udiDi>10850037993014</udiDi>
    <basicUdiDi>10850037993014H9</basicUdiDi>
    <tradeName>10850037993014</tradeName>
    <deviceName>Two Concave Stimulus Electrodes</deviceName>
    <manufacturerName>MECTA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019538</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109002</emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9010-0008-01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:24:45.694Z</lastUpdated>
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  <row>
    <udiDi>10850037993007</udiDi>
    <basicUdiDi>10850037993007HC</basicUdiDi>
    <tradeName>10850037993007</tradeName>
    <deviceName>Two Flat Stimulus Electrodes</deviceName>
    <manufacturerName>MECTA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019538</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109002</emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9010-0009-01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:24:44.900Z</lastUpdated>
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  <row>
    <udiDi>00768627014595</udiDi>
    <basicUdiDi>0768627ORTHO-4030-N3</basicUdiDi>
    <tradeName>Norco Nite-Nite Neutral Wrist Support</tradeName>
    <deviceName></deviceName>
    <manufacturerName>North Coast Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009087</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC12220</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:41:47.594Z</lastUpdated>
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  <row>
    <udiDi>00819833020006</udiDi>
    <basicUdiDi>081983302CarillonB5</basicUdiDi>
    <tradeName>Carillon Mitral Contour System (CMCS)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Dimensions, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002426</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAT-1515-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:12.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819833020013</udiDi>
    <basicUdiDi>081983302CarillonB5</basicUdiDi>
    <tradeName>Carillon Mitral Contour System (CMCS)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Dimensions, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002426</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAT-1515-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:12.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819833020020</udiDi>
    <basicUdiDi>081983302CarillonB5</basicUdiDi>
    <tradeName>Carillon Mitral Contour System (CMCS)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Dimensions, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002426</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAT-1515-03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:12.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819833020037</udiDi>
    <basicUdiDi>081983302CarillonB5</basicUdiDi>
    <tradeName>Carillon Mitral Contour System (CMCS)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Dimensions, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002426</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAT-1515-04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:12.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819833020044</udiDi>
    <basicUdiDi>081983302CarillonB5</basicUdiDi>
    <tradeName>Carillon Mitral Contour System (CMCS)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Dimensions, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002426</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAT-1515-05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:12.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819833020051</udiDi>
    <basicUdiDi>081983302CarillonB5</basicUdiDi>
    <tradeName>Carillon Mitral Contour System (CMCS)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Dimensions, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002426</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAT-1515-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:12.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819833020068</udiDi>
    <basicUdiDi>081983302CarillonB5</basicUdiDi>
    <tradeName>Carillon Mitral Contour System (CMCS)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Dimensions, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002426</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAT-1515-07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:12.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819833020075</udiDi>
    <basicUdiDi>081983302CarillonB5</basicUdiDi>
    <tradeName>Carillon Mitral Contour System (CMCS)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Dimensions, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002426</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAT-1515-08</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:12.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819833020082</udiDi>
    <basicUdiDi>081983302CarillonB5</basicUdiDi>
    <tradeName>Carillon Mitral Contour System (CMCS)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Dimensions, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002426</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAT-1515-09</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:12.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819833020099</udiDi>
    <basicUdiDi>081983302CarillonB5</basicUdiDi>
    <tradeName>Carillon Mitral Contour System (CMCS)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Dimensions, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002426</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAT-1515-10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:12.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819833020105</udiDi>
    <basicUdiDi>081983302CarillonB5</basicUdiDi>
    <tradeName>Carillon Mitral Contour System (CMCS)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Dimensions, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002426</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAT-1515-11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:12.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819833020112</udiDi>
    <basicUdiDi>081983302CarillonB5</basicUdiDi>
    <tradeName>Carillon Mitral Contour System (CMCS)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Dimensions, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002426</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAT-1515-12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:12.443Z</lastUpdated>
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