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    <deviceName>spECTrum Dual Hand-Helds without 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>
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    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9438-0078-02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:35:01.030Z</lastUpdated>
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    <deviceName>spECTrum Single Hand-Held with Remote</deviceName>
    <manufacturerName>MECTA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019538</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
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    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9438-0076-02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:35:00.227Z</lastUpdated>
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    <deviceName>spECTrum Single Hand-Held without Remote</deviceName>
    <manufacturerName>MECTA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019538</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
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    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9438-0077-02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:34:58.640Z</lastUpdated>
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    <udiDi>00850037993055</udiDi>
    <basicUdiDi>00850037993055GC</basicUdiDi>
    <tradeName>00850037993055</tradeName>
    <deviceName>spECTrum 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>9438-0073</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:34:55.451Z</lastUpdated>
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    <udiDi>00861539000189</udiDi>
    <basicUdiDi>B-00861539000189</basicUdiDi>
    <tradeName>00861539000189</tradeName>
    <deviceName>MECTA Sigma 200 J</deviceName>
    <manufacturerName>MECTA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019538</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12109002</emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9438-5001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:48:05.385Z</lastUpdated>
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    <udiDi>00861539000172</udiDi>
    <basicUdiDi>B-00861539000172</basicUdiDi>
    <tradeName>00861539000172</tradeName>
    <deviceName>spECTrum 5000CEM</deviceName>
    <manufacturerName>MECTA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019538</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12109002</emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9438-3024</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:48:04.588Z</lastUpdated>
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    <udiDi>00861539000165</udiDi>
    <basicUdiDi>B-00861539000165</basicUdiDi>
    <tradeName>00861539000165</tradeName>
    <deviceName>spECTrum 4000CEQ</deviceName>
    <manufacturerName>MECTA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019538</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9438-3027</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:46:01.308Z</lastUpdated>
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    <udiDi>00861539000158</udiDi>
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    <tradeName>00861539000158</tradeName>
    <deviceName>spECTrum 4000CEM</deviceName>
    <manufacturerName>MECTA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019538</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>Z12109002</emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9438-3026</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:45:59.704Z</lastUpdated>
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    <udiDi>00861539000141</udiDi>
    <basicUdiDi>B-00861539000141</basicUdiDi>
    <tradeName>00861539000141</tradeName>
    <deviceName>spECTrum 5000CEQ</deviceName>
    <manufacturerName>MECTA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019538</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12109002</emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9438-3025</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:45:58.913Z</lastUpdated>
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  <row>
    <udiDi>00850298007003</udiDi>
    <basicUdiDi>B-00850298007003</basicUdiDi>
    <tradeName>Thymatron System IV</tradeName>
    <deviceName>Thymatron System IV</deviceName>
    <manufacturerName>Somatics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000011550</manufacturerSrn>
    <authorisedRepresentativeName>FBI Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009421</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12109002</emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EDIV</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:08:52.690Z</lastUpdated>
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  <row>
    <udiDi>00850045508005</udiDi>
    <basicUdiDi>B-00850045508005</basicUdiDi>
    <tradeName>00850045508005</tradeName>
    <deviceName>SigmaStim Σigma 200J</deviceName>
    <manufacturerName>SigmaStim Domestic LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029359</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12109002</emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9438-5001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:08.120Z</lastUpdated>
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  <row>
    <udiDi>06262298000047</udiDi>
    <basicUdiDi>62622980GAG-1E2</basicUdiDi>
    <tradeName>ECT Mouth Guard (Disposable Bite Block)</tradeName>
    <deviceName>ECT Mouth Guard</deviceName>
    <manufacturerName>Dadeh Gostaran Dena</manufacturerName>
    <manufacturerSrn>IR-MF-000038532</manufacturerSrn>
    <authorisedRepresentativeName>Eska Diagnostics Kft</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000037211</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>GAG-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:33:30.269Z</lastUpdated>
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    <udiDi>10860007792516</udiDi>
    <basicUdiDi>10860007792516GB</basicUdiDi>
    <tradeName>10860007792516</tradeName>
    <deviceName>ECT Cotton Bite Blocks Size Medium</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>9391-0003 M</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:26:02.871Z</lastUpdated>
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    <udiDi>10860007792509</udiDi>
    <basicUdiDi>10860007792509GE</basicUdiDi>
    <tradeName>10860007792509</tradeName>
    <deviceName>ECT Cotton Bite Blocks Size Large</deviceName>
    <manufacturerName>MECTA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019538</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
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    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9391-0003 L</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:26:01.272Z</lastUpdated>
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    <udiDi>10850045508309</udiDi>
    <basicUdiDi>10850045508309DU</basicUdiDi>
    <tradeName>10850045508309</tradeName>
    <deviceName>spECTrum EEG/ECG Five-Lead Set-IEC (replacement)</deviceName>
    <manufacturerName>SigmaStim Domestic LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029359</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
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    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9010-0011-12</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:25:59.127Z</lastUpdated>
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    <deviceName>spECTrum EEG/ECG Five-Lead Set (replacement)</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>Artık piyasada değil</deviceStatus>
    <reference>9010-0011-11</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:25:57.265Z</lastUpdated>
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    <deviceName>spECTrum Safety Monitor Cable IEC EEG/ECG (replacement)</deviceName>
    <manufacturerName>SigmaStim Domestic LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029359</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
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    <deviceStatus>Artık piyasada değil</deviceStatus>
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    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:25:56.491Z</lastUpdated>
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    <deviceName>spECTrum Safety Monitor Cable DOM EEG/ECG (replacement)</deviceName>
    <manufacturerName>SigmaStim Domestic LLC</manufacturerName>
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    <deviceStatus>Artık piyasada değil</deviceStatus>
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    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:25:54.864Z</lastUpdated>
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    <deviceName>ECG Safety Leads IEC (Red, Green, Yellow)</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>9011-0001-02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:25:52.662Z</lastUpdated>
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    <manufacturerName>SigmaStim Domestic LLC</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:25:50.869Z</lastUpdated>
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