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MECTA LLC

United States·US-MF-000019538

Last updated September 18, 2026

Information

Country: United States
Address: 19799 SW 95th AVENUE, TUALATIN, OREGON, United States
Website: www.mectacorp.com
This address returned "not found" when we last checked — the site may have moved. Last checked 2026-09-18.
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 503 612 6780
PRRC Contact: Adrian Kettering
EUDAMED SRN: US-MF-000019538
FDA FEI Number: —
DUNS Number: —

Catalogue (45)

Device	Model / Reference	Registries	Class	Status
spECTrum	5000DQ	FDA UDI	Class III	Active
spECTrum	5000DM	FDA UDI	Class III	Active
spECTrum	4000DQ	FDA UDI	Class III	Active
spECTrum	4000DM	FDA UDI	Class III	Active
ECT Cotton Bite Blocks Size Medium	9391-0003 M	EUDAMED	Class I	Active
EEG Safety Leads (Gray)	9013-0001-02	EUDAMED	Class I	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
ECG Safety Leads (White, Green, Black)	9011-0001-01	EUDAMED	Class I	Active
Sigma Dual Hand-Held Electrode Assembly with Push Button	9438-0175	EUDAMED	Class I	Active
spECTrum Patient Stimulus Cable	9438-0073	EUDAMED	Class I	Active
OMS Cable	9438-0102-01	EUDAMED	Class I	Active
spECTrum 5000CEQ	9438-3025	EUDAMED	Class IIb	Active
Two Flat Stimulus Electrodes	9010-0009-01	EUDAMED	Class I	Active
spECTrum 5000CEM	9438-3024	EUDAMED	Class IIb	Active
Sigma EMR Software	9020-0020	EUDAMED	Class I	Active
EEG Safety Leads (Brown)	9013-0001-01	EUDAMED	Class I	Active
spECTrum Single Hand-Held without Remote	9438-0077-02	EUDAMED	Class I	Active
Mecta Ect Device Models Sr & Jr	K852069	FDA 510(k)	Class II	Active
Spectrum 5000 Q, 5000 M, 4000 Q, 4000 M	K960754	FDA 510(k)	Class II	Active
Spectrum 5000 Q, 5000q, M, 4000 Q, 4000 M.	K965070	FDA 510(k)	Class II	Active
spECTrum Safety Monitor Cable DOM EEG/ECG	9010-0011-01	EUDAMED	Class I	Active
Sigma Patient Stimulus Cable	9438-0173	EUDAMED	Class I	Active
spECTrum Safety Monitor Cable IEC EEG/ECG	9010-0011-02	EUDAMED	Class I	Active
spECTrum EMR Software	9020-0015	EUDAMED	Class I	Active
spECTrum 4000CEM	9438-3026	EUDAMED	Class IIb	Active
ECG Safety Leads IEC (Red, Green, Yellow)	9011-0001-02	EUDAMED	Class I	Active
EEG/EEG Five-Lead Set	9010-0011-13	EUDAMED	Class I	Active
ECT Cotton Bite Blocks Size Large	9391-0003 L	EUDAMED	Class I	Active
Sigma Dual Hand-Held Electrode Assembly without Push Button	9438-0178	EUDAMED	Class I	Active
spECTrum Dual Hand-Helds without Remote	9438-0078-02	EUDAMED	Class I	Active
spECTrum 4000CEQ	9438-3027	EUDAMED	Class IIb	Active
EEG/ECG Five-Lead Set	9010-0011-11	EUDAMED	Class I	Active
Sigma Safety Monitor Cable IEC ECG/EMG	9010-0011-06	EUDAMED	Class I	Active
Sigma Safety Monitor Cable DOM ECG/EMG	9010-0011-05	EUDAMED	Class I	Active
spECTrum Single Hand-Held with Remote	9438-0076-02	EUDAMED	Class I	Active
spECTrum Dual Hand-Helds with Remote	9438-0075-02	EUDAMED	Class I	Active
EEG/ECG Five-Lead Set-IEC	9010-0011-12	EUDAMED	Class I	Active
EEG Green Reference Lead	9013-0001-03	EUDAMED	Class I	Active
Two Concave Stimulus Electrodes	9010-0008-01	EUDAMED	Class I	Active
Safety Monitor Cable EEG1/EEG2	9010-0011-03	EUDAMED	Class I	Active
MECTA Sigma 200 J	9438-5001	EUDAMED	Class IIb	Active
Sigma Single Hand-Held Electrode Assembly with Push Button	9438-0176	EUDAMED	Class I	Active
Adjustable Headband	9825-0001-01	EUDAMED	Class I	Active
EMG Safety Leads (Blue)	9013-0010	EUDAMED	Class I	Active

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