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    <deviceName>ECT Cotton Bite Blocks Size Medium</deviceName>
    <manufacturerName>SigmaStim Domestic LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029359</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9391-0003 M</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:25:38.070Z</lastUpdated>
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    <deviceName>ECT Cotton Bite Blocks Size Large</deviceName>
    <manufacturerName>SigmaStim Domestic LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029359</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
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    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9391-0003 L</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:25:37.262Z</lastUpdated>
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    <deviceName>EEG Safety Leads (Gray)</deviceName>
    <manufacturerName>SigmaStim Domestic LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029359</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
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    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9013-0001-02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:25:35.670Z</lastUpdated>
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    <udiDi>10850045508057</udiDi>
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    <tradeName>10850045508057</tradeName>
    <deviceName>EMG Safety Leads (Blue)</deviceName>
    <manufacturerName>SigmaStim Domestic LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029359</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>Piyasada</deviceStatus>
    <reference>9013-0010</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:25:33.256Z</lastUpdated>
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    <udiDi>10850045508040</udiDi>
    <basicUdiDi>10850045508040D7</basicUdiDi>
    <tradeName>10850045508040</tradeName>
    <deviceName>EEG Safety Leads (Brown)</deviceName>
    <manufacturerName>SigmaStim Domestic LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029359</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>Piyasada</deviceStatus>
    <reference>9013-0001-01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:25:31.668Z</lastUpdated>
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    <udiDi>10850045508033</udiDi>
    <basicUdiDi>10850045508033DA</basicUdiDi>
    <tradeName>10850045508033</tradeName>
    <deviceName>Two Concave Stimulus Electrodes</deviceName>
    <manufacturerName>SigmaStim Domestic LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029359</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>Piyasada</deviceStatus>
    <reference>9010-0008-01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:25:31.219Z</lastUpdated>
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    <udiDi>10850045508026</udiDi>
    <basicUdiDi>10850045508026DD</basicUdiDi>
    <tradeName>10850045508026</tradeName>
    <deviceName>Two Flat Stimulus Electrodes</deviceName>
    <manufacturerName>SigmaStim Domestic LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029359</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>Piyasada</deviceStatus>
    <reference>9010-0009-01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:25:29.269Z</lastUpdated>
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    <udiDi>10850037993281</udiDi>
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    <deviceName>EEG/EEG Five-Lead Set</deviceName>
    <manufacturerName>MECTA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019538</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Z12109002</emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9010-0011-13</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:25:26.861Z</lastUpdated>
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    <udiDi>10850037993274</udiDi>
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    <tradeName>10850037993274</tradeName>
    <deviceName>EEG/ECG Five-Lead Set-IEC</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>9010-0011-12</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:25:25.263Z</lastUpdated>
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    <udiDi>10850037993304</udiDi>
    <basicUdiDi>10850037993304HM</basicUdiDi>
    <tradeName>10850037993304</tradeName>
    <deviceName>ECG Safety Leads IEC (Red, Green, Yellow)</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>9011-0001-02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:25:24.459Z</lastUpdated>
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    <udiDi>10850037993298</udiDi>
    <basicUdiDi>10850037993298JK</basicUdiDi>
    <tradeName>10850037993298</tradeName>
    <deviceName>ECG Safety Leads (White, Green, Black)</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>9011-0001-01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:25:22.881Z</lastUpdated>
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    <udiDi>10850037993267</udiDi>
    <basicUdiDi>10850037993267J8</basicUdiDi>
    <tradeName>10850037993267</tradeName>
    <deviceName>EEG/ECG Five-Lead Set</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>9010-0011-11</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:25:06.508Z</lastUpdated>
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    <udiDi>10850037993250</udiDi>
    <basicUdiDi>10850037993250HP</basicUdiDi>
    <tradeName>10850037993250</tradeName>
    <deviceName>Sigma EMR Software</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>9020-0020</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:25:05.713Z</lastUpdated>
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    <udiDi>10850037993243</udiDi>
    <basicUdiDi>10850037993243HS</basicUdiDi>
    <tradeName>10850037993243</tradeName>
    <deviceName>EEG Green Reference Lead</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>9013-0001-03</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:25:04.906Z</lastUpdated>
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    <udiDi>10850037993236</udiDi>
    <basicUdiDi>10850037993236HV</basicUdiDi>
    <tradeName>10850037993236</tradeName>
    <deviceName>Safety Monitor Cable EEG3/EEG4</deviceName>
    <manufacturerName>MECTA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019538</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109002</emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9010-0011-04</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:25:04.101Z</lastUpdated>
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    <deviceName>Safety Monitor Cable EEG1/EEG2</deviceName>
    <manufacturerName>MECTA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019538</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
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    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9010-0011-03</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:25:00.100Z</lastUpdated>
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    <udiDi>10850037993205</udiDi>
    <basicUdiDi>10850037993205HJ</basicUdiDi>
    <tradeName>10850037993205</tradeName>
    <deviceName>Adjustable Headband</deviceName>
    <manufacturerName>MECTA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019538</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Z12109002</emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9825-0001-01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:24:59.294Z</lastUpdated>
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    <udiDi>10850037993199</udiDi>
    <basicUdiDi>10850037993199JG</basicUdiDi>
    <tradeName>10850037993199</tradeName>
    <deviceName>Sigma Safety Monitor Cable IEC ECG/EMG</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>9010-0011-06</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:24:58.506Z</lastUpdated>
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    <deviceName>Sigma Safety Monitor Cable DOM ECG/EMG</deviceName>
    <manufacturerName>MECTA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019538</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Z12109002</emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9010-0011-05</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:24:57.696Z</lastUpdated>
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    <basicUdiDi>10850037993120H9</basicUdiDi>
    <tradeName>10850037993120</tradeName>
    <deviceName>spECTrum EMR Software</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>9020-0015</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:24:53.694Z</lastUpdated>
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