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    <udiDi>00850298007201</udiDi>
    <basicUdiDi>08502980072095</basicUdiDi>
    <tradeName>ECT Treatment Cable</tradeName>
    <deviceName>ECT Treatment Cable/Bk</deviceName>
    <manufacturerName>Somatics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000011550</manufacturerSrn>
    <authorisedRepresentativeName>FBI Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009421</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109002</emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECET-P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:32:36.279Z</lastUpdated>
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  <row>
    <udiDi>00850298007164</udiDi>
    <basicUdiDi>0850298007169E</basicUdiDi>
    <tradeName>00850298007164</tradeName>
    <deviceName>Remote Treatment Handle</deviceName>
    <manufacturerName>Somatics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000011550</manufacturerSrn>
    <authorisedRepresentativeName>FBI Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009421</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109002</emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ERTH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:32:31.467Z</lastUpdated>
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  <row>
    <udiDi>00850045508357</udiDi>
    <basicUdiDi>00850045508357CU</basicUdiDi>
    <tradeName>00850045508357</tradeName>
    <deviceName>spECTrum Dual Hand-Held w/o Remote (replacement)</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>Artık piyasada değil</deviceStatus>
    <reference>9438-0078-02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:35:47.698Z</lastUpdated>
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    <udiDi>00850045508340</udiDi>
    <basicUdiDi>00850045508340CB</basicUdiDi>
    <tradeName>00850045508340</tradeName>
    <deviceName>spECTrum Single Hand-Held w/o Remote (replacement)</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>Artık piyasada değil</deviceStatus>
    <reference>9438-0077-02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:35:43.186Z</lastUpdated>
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  <row>
    <udiDi>00850045508326</udiDi>
    <basicUdiDi>00850045508326CH</basicUdiDi>
    <tradeName>00850045508326</tradeName>
    <deviceName>spECTrum Dual Hand-Held w/ Remote (replacement)</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>Artık piyasada değil</deviceStatus>
    <reference>9438-0075-02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:35:41.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850045508333</udiDi>
    <basicUdiDi>00850045508333CE</basicUdiDi>
    <tradeName>00850045508333</tradeName>
    <deviceName>spECTrum Single Hand-Held w/Remote (replacement)</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>Artık piyasada değil</deviceStatus>
    <reference>9438-0076-02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:35:41.291Z</lastUpdated>
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  <row>
    <udiDi>00850045508319</udiDi>
    <basicUdiDi>00850045508319CL</basicUdiDi>
    <tradeName>00850045508319</tradeName>
    <deviceName>spECTrum Patient Stimulus Cable (replacement)</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>Artık piyasada değil</deviceStatus>
    <reference>9438-0073</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:35:39.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850045508173</udiDi>
    <basicUdiDi>00850045508173CG</basicUdiDi>
    <tradeName>00850045508173</tradeName>
    <deviceName>OMS Cable</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>Artık piyasada değil</deviceStatus>
    <reference>9438-0102-01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:35:36.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850045508128</udiDi>
    <basicUdiDi>00850045508128CB</basicUdiDi>
    <tradeName>00850045508128</tradeName>
    <deviceName>Sigma Dual Hand-Held Electrode Assembly without Push Button</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>9438-0178</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:35:35.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850045508135</udiDi>
    <basicUdiDi>00850045508135C8</basicUdiDi>
    <tradeName>00850045508135</tradeName>
    <deviceName>Sigma Dual Hand-Held Electrode Assembly with Push Button</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>9438-0175</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:35:34.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850045508111</udiDi>
    <basicUdiDi>00850045508111BS</basicUdiDi>
    <tradeName>00850045508111</tradeName>
    <deviceName>Sigma Single Hand-Held Electrode Assembly with Push Button</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>9438-0176</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:35:32.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850037993215</udiDi>
    <basicUdiDi>00850037993215GA</basicUdiDi>
    <tradeName>00850037993215</tradeName>
    <deviceName>OMS Cable</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>9438-0102-01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:35:31.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850045508104</udiDi>
    <basicUdiDi>00850045508104BV</basicUdiDi>
    <tradeName>00850045508104</tradeName>
    <deviceName>Sigma Single Hand-Held Electrode Assembly without Push Button</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>9438-0177</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:35:27.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850045508098</udiDi>
    <basicUdiDi>00850045508098CT</basicUdiDi>
    <tradeName>00850045508098</tradeName>
    <deviceName>Sigma Patient Stimulus Cable</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>9438-0173</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:35:27.174Z</lastUpdated>
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  <row>
    <udiDi>00850037993178</udiDi>
    <basicUdiDi>00850037993178GV</basicUdiDi>
    <tradeName>00850037993178</tradeName>
    <deviceName>Sigma Dual Hand-Held Electrode Assembly with Push Button</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>9438-0175</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:35:25.173Z</lastUpdated>
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  <row>
    <udiDi>00850037993161</udiDi>
    <basicUdiDi>00850037993161GC</basicUdiDi>
    <tradeName>00850037993161</tradeName>
    <deviceName>Sigma Dual Hand-Held Electrode Assembly without Push Button</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>9438-0178</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:35:09.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850037993154</udiDi>
    <basicUdiDi>00850037993154GF</basicUdiDi>
    <tradeName>00850037993154</tradeName>
    <deviceName>Sigma Single Hand-Held Electrode Assembly with Push Button</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>9438-0176</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:35:07.434Z</lastUpdated>
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  <row>
    <udiDi>00850037993147</udiDi>
    <basicUdiDi>00850037993147GJ</basicUdiDi>
    <tradeName>00850037993147</tradeName>
    <deviceName>Sigma Single Hand-Held Electrode Assembly without Push Button</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>9438-0177</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:35:06.633Z</lastUpdated>
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  <row>
    <udiDi>00850037993130</udiDi>
    <basicUdiDi>00850037993130FZ</basicUdiDi>
    <tradeName>00850037993130</tradeName>
    <deviceName>Sigma Patient Stimulus Cable</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>9438-0173</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:35:05.134Z</lastUpdated>
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  <row>
    <udiDi>00850037993093</udiDi>
    <basicUdiDi>00850037993093GL</basicUdiDi>
    <tradeName>00850037993093</tradeName>
    <deviceName>spECTrum Dual Hand-Helds with Remote</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>9438-0075-02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:35:02.909Z</lastUpdated>
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