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SigmaStim Domestic LLC

United States·US-MF-000029359

Last updated September 17, 2026

About

Contact 911 in case of a medical or mental health emergency. SigmaStim does not sell, nor provide service, to third parties.

From the manufacturer's own website. Source

Information

Country: United States
Address: 19799, SW 95th Avenue, TUALATIN, OREGON, United States
Website: sigmastim.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 503-612-1881
PRRC Contact: Adrian Kettering
EUDAMED SRN: US-MF-000029359
FDA FEI Number: 3023869663
DUNS Number: —

Catalogue (32)

Device	Model / Reference	Registries	Class	Status
Sigma Dual Hand-Held Electrode Assembly without Push Button	9438-0178	EUDAMED	Class I	Active
EEG/EEG Five-Lead Set	9010-0011-13	EUDAMED	Class I	Active
spECTrum Single Hand-Held w/Remote (replacement)	9438-0076-02	EUDAMED	Class I	Active
Adjustable Headband	9825-0001-01	EUDAMED	Class I	Active
ECT Cotton Bite Blocks Size Large	9391-0003 L	EUDAMEDFDA UDI	Class I	Active
Sigma Safety Monitor Cable DOM ECG/EMG	9010-0011-05	EUDAMED	Class I	Active
Sigma Patient Stimulus Cable	9438-0173	EUDAMED	Class I	Active
spECTrum EEG/ECG Five-Lead Set-IEC (replacement)	9010-0011-12	EUDAMED	Class I	Active
Sigma Safety Monitor Cable IEC ECG/EMG	9010-0011-06	EUDAMED	Class I	Active
spECTrum Safety Monitor Cable IEC EEG/ECG (replacement)	9010-0011-02	EUDAMED	Class I	Active
ECT Cotton Bite Blocks Size Medium	9391-0003 M	EUDAMEDFDA UDI	Class I	Active
spECTrum Safety Monitor Cable DOM EEG/ECG (replacement)	9010-0011-01	EUDAMED	Class I	Active
OMS Cable	9438-0102-01	EUDAMED	Class I	Active
Safety Monitor Cable EEG1/EEG2	9010-0011-03	EUDAMED	Class I	Active
EEG Safety Leads (Brown)	9013-0001-01	EUDAMED	Class I	Active
spECTrum Dual Hand-Held w/o Remote (replacement)	9438-0078-02	EUDAMED	Class I	Active
spECTrum Dual Hand-Held w/ Remote (replacement)	9438-0075-02	EUDAMED	Class I	Active
spECTrum Patient Stimulus Cable (replacement)	9438-0073	EUDAMED	Class I	Active
Sigma Single Hand-Held Electrode Assembly with Push Button	9438-0176	EUDAMED	Class I	Active
EMG Safety Leads (Blue)	9013-0010	EUDAMED	Class I	Active
ECG Safety Leads (White, Green, Black)	9011-0001-01	EUDAMED	Class I	Active
spECTrum Single Hand-Held w/o Remote (replacement)	9438-0077-02	EUDAMED	Class I	Active
Two Concave Stimulus Electrodes	9010-0008-01	EUDAMED	Class I	Active
EEG Safety Leads (Gray)	9013-0001-02	EUDAMED	Class I	Active
SigmaStim Σigma 200J	9438-5001	EUDAMEDFDA UDI	Class IIb	Active
Safety Monitor Cable EEG3/EEG4	9010-0011-04	EUDAMED	Class I	Active
Sigma Single Hand-Held Electrode Assembly without Push Button	9438-0177	EUDAMED	Class I	Active
spECTrum EEG/ECG Five-Lead Set (replacement)	9010-0011-11	EUDAMED	Class I	Active
Sigma Dual Hand-Held Electrode Assembly with Push Button	9438-0175	EUDAMED	Class I	Active
EEG Green Reference Lead	9013-0001-03	EUDAMED	Class I	Active
ECG Safety Leads IEC (Red, Green, Yellow)	9011-0001-02	EUDAMED	Class I	Active
Two Flat Stimulus Electrodes	9010-0009-01	EUDAMED	Class I	Active

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