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    <basicUdiDi>081674402BP4DG</basicUdiDi>
    <tradeName>NICO BrainPath</tradeName>
    <deviceName>Shepherd's Hook</deviceName>
    <manufacturerName>NICO Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000000769</manufacturerSrn>
    <authorisedRepresentativeName>Atlantico Systems, Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000208</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109099</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NN-8024</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:22:11.517Z</lastUpdated>
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    <udiDi>00816744022501</udiDi>
    <basicUdiDi>081674402PP1FG</basicUdiDi>
    <tradeName>NICO BrainPath Approach</tradeName>
    <deviceName>NICO BrainPath Approach</deviceName>
    <manufacturerName>NICO Corporation</manufacturerName>
    <manufacturerSrn>US-PR-000035011</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109099</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NN-2500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:22:00.692Z</lastUpdated>
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    <udiDi>00811852030318</udiDi>
    <basicUdiDi>081185203VIZICHBG</basicUdiDi>
    <tradeName>Viz ICH</tradeName>
    <deviceName>Viz ICH</deviceName>
    <manufacturerName>Viz.ai</manufacturerName>
    <manufacturerSrn>US-MF-000024837</manufacturerSrn>
    <authorisedRepresentativeName>AJW Technology Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109082</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>081185203VIZICHBG</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:11:21.932Z</lastUpdated>
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    <udiDi>00811852030301</udiDi>
    <basicUdiDi>081185203VIZLVOE6</basicUdiDi>
    <tradeName>Viz LVO</tradeName>
    <deviceName>Viz LVO</deviceName>
    <manufacturerName>Viz.ai</manufacturerName>
    <manufacturerSrn>US-MF-000024837</manufacturerSrn>
    <authorisedRepresentativeName>AJW Technology Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109082</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>081185203VIZLVOE6</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:11:21.725Z</lastUpdated>
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    <udiDi>00811852030288</udiDi>
    <basicUdiDi>081185203VIZCTPCM</basicUdiDi>
    <tradeName>Viz CTP</tradeName>
    <deviceName>Viz CTP</deviceName>
    <manufacturerName>Viz.ai</manufacturerName>
    <manufacturerSrn>US-MF-000024837</manufacturerSrn>
    <authorisedRepresentativeName>AJW Technology Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109082</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>081185203VIZCTPCM</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:11:17.128Z</lastUpdated>
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  <row>
    <udiDi>08056446900642</udiDi>
    <basicUdiDi>080564469MDSW_EK</basicUdiDi>
    <tradeName>Galileo NExT</tradeName>
    <deviceName>MDSW Family</deviceName>
    <manufacturerName>EB Neuro S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000027944</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109092</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B8640053000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:32:39.895Z</lastUpdated>
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  <row>
    <udiDi>08056446900000</udiDi>
    <basicUdiDi>080564469EEG_BE</basicUdiDi>
    <tradeName>BE Micro</tradeName>
    <deviceName>EEG Family</deviceName>
    <manufacturerName>EB Neuro S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000027944</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109099</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B9800073000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:32:38.291Z</lastUpdated>
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  <row>
    <udiDi>10381780521327</udiDi>
    <basicUdiDi>038178B0076CSS4R</basicUdiDi>
    <tradeName>CODMAN CERTAS®</tradeName>
    <deviceName>ICP Programmer</deviceName>
    <manufacturerName>Integra LifeSciences Production Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000009189</manufacturerSrn>
    <authorisedRepresentativeName>Integra LifeSciences Services</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000002474</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109003</emdnCode>
    <emdnDescription>CEREBROSPINAL FLUID PRESSURE MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>82-8851</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:29:25.386Z</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>
  </row>
  <row>
    <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>
  </row>
  <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>
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  <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>
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  <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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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