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    <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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    <udiDi>00850298007010</udiDi>
    <basicUdiDi>0850298007018Z</basicUdiDi>
    <tradeName>Thymapad</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NEUROPHYSIOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EPAD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:56.089Z</lastUpdated>
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    <udiDi>00850298007027</udiDi>
    <basicUdiDi>08502980070293</basicUdiDi>
    <tradeName>Stick on Snap On Disposable Recording Electrodes</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ECG ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EEDS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:56.074Z</lastUpdated>
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    <udiDi>00850298007034</udiDi>
    <basicUdiDi>08502980070395</basicUdiDi>
    <tradeName>Disposable Oral Protectors for ECT</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INTUBATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VENT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:56.060Z</lastUpdated>
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    <udiDi>00850298007041</udiDi>
    <basicUdiDi>08502980070497</basicUdiDi>
    <tradeName>Oral Protector</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EMGD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:56.042Z</lastUpdated>
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    <udiDi>00850298007058</udiDi>
    <basicUdiDi>08502980070599</basicUdiDi>
    <tradeName>00850298007058</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EMGS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:56.017Z</lastUpdated>
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    <udiDi>00850298007065</udiDi>
    <basicUdiDi>08502980070395</basicUdiDi>
    <tradeName>VENTIL-A</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VENT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:56.000Z</lastUpdated>
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    <udiDi>00850298007072</udiDi>
    <basicUdiDi>0850298007079D</basicUdiDi>
    <tradeName>Monitoring Lead Wires for Thymatron System IV 24" Leads Set of 9</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIAC DIAGNOSTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELDSC-9</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:55.988Z</lastUpdated>
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    <udiDi>00850298007089</udiDi>
    <basicUdiDi>0850298007089F</basicUdiDi>
    <tradeName>Monitoring Lead Wires for Thymatron System IV 24" Leads Set of 5</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELDSC-5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:55.979Z</lastUpdated>
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    <udiDi>00850298007096</udiDi>
    <basicUdiDi>0850298007099H</basicUdiDi>
    <tradeName>00850298007096</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, CONVENTIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELDS-BR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:55.968Z</lastUpdated>
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    <udiDi>00850298007140</udiDi>
    <basicUdiDi>08502980071092</basicUdiDi>
    <tradeName>Stainless Steel Electrode FLAT BiLateral</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELECTRODES AND PROBES CUTANEOUS CONDUCTIVE SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EEFL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:55.959Z</lastUpdated>
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    <udiDi>00850298007157</udiDi>
    <basicUdiDi>0850298007159C</basicUdiDi>
    <tradeName>00850298007157</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EECU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:55.947Z</lastUpdated>
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    <udiDi>00850298007164</udiDi>
    <basicUdiDi>0850298007169E</basicUdiDi>
    <tradeName>00850298007164</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ERTH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:55.935Z</lastUpdated>
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    <udiDi>00850298007188</udiDi>
    <basicUdiDi>0850298007189J</basicUdiDi>
    <tradeName>00850298007188</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EHAN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:55.916Z</lastUpdated>
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    <udiDi>00850298007195</udiDi>
    <basicUdiDi>0850298007199L</basicUdiDi>
    <tradeName>Foam Pressure Applicator Handle</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ECG ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EHAN-S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:55.903Z</lastUpdated>
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    <udiDi>00850298007201</udiDi>
    <basicUdiDi>08502980072095</basicUdiDi>
    <tradeName>ECT Treatment Cable</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECET-P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:55.890Z</lastUpdated>
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    <udiDi>00850298007218</udiDi>
    <basicUdiDi>08502980072197</basicUdiDi>
    <tradeName>00850298007218</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECEF-4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:55.872Z</lastUpdated>
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