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Snapshot 2026-10-25 · Link to EUDAMED

SigmaStim Domestic LLC

SRN US-MF-000029359

manufacturer · TUALATIN, OREGON, US · 32 devices

19799 SW 95th Avenue, 97062

Devices

NameUDI-DIClassBadge
Adjustable Headband10850045508163Class I
No Certificate Found

Snapshot 2026-10-25 · Link to EUDAMED

ECG Safety Leads IEC (Red, Green, Yellow)10850045508255Class I
No Certificate Found

Snapshot 2026-10-25 · Link to EUDAMED

ECG Safety Leads (White, Green, Black)10850045508248Class I
No Certificate Found

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ECT Cotton Bite Blocks Size Large10850045508071Class I
No Certificate Found

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ECT Cotton Bite Blocks Size Medium10850045508088Class I
No Certificate Found

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EEG/EEG Five-Lead Set10850045508231Class I
No Certificate Found

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EEG Green Reference Lead10850045508200Class I
No Certificate Found

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EEG Safety Leads (Brown)10850045508040Class I
No Certificate Found

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EEG Safety Leads (Gray)10850045508064Class I
No Certificate Found

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EMG Safety Leads (Blue)10850045508057Class I
No Certificate Found

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OMS Cable00850045508173Class I
No Certificate Found

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Safety Monitor Cable EEG1/EEG210850045508187Class I
No Certificate Found

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Safety Monitor Cable EEG3/EEG410850045508194Class I
No Certificate Found

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Sigma Dual Hand-Held Electrode Assembly without Push Button00850045508128Class I
No Certificate Found

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Sigma Dual Hand-Held Electrode Assembly with Push Button00850045508135Class I
No Certificate Found

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Sigma Patient Stimulus Cable00850045508098Class I
No Certificate Found

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Sigma Safety Monitor Cable DOM ECG/EMG10850045508149Class I
No Certificate Found

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Sigma Safety Monitor Cable IEC ECG/EMG10850045508156Class I
No Certificate Found

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Sigma Single Hand-Held Electrode Assembly without Push Button00850045508104Class I
No Certificate Found

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Sigma Single Hand-Held Electrode Assembly with Push Button00850045508111Class I
No Certificate Found

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SigmaStim Σigma 200J00850045508005Class IIb
No Certificate Found

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spECTrum Dual Hand-Held w/o Remote (replacement)00850045508357Class I
No Certificate Found

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spECTrum Dual Hand-Held w/ Remote (replacement)00850045508326Class I
No Certificate Found

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spECTrum EEG/ECG Five-Lead Set-IEC (replacement)10850045508309Class I
No Certificate Found

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spECTrum EEG/ECG Five-Lead Set (replacement)10850045508293Class I
No Certificate Found

Snapshot 2026-10-25 · Link to EUDAMED

SigmaStim Domestic LLC (SRN US-MF-000029359) — registered devices | UDI Compass