Manufacturer

Sigmastim

United StatesLegal entities : SigmaStim Domestic LLC

Markets : Belgium · United States

Approvals : EU – class I, IIb · United States (FDA) – · class II

EU representative : ICON (LR) Limited (Ireland)

Website

1 category, 32 models including 22 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Electroconvulsive therapy (ect) equipment	Z12109002	Adjustable Headband ECG Safety Leads (White, Green, Black) ECG Safety Leads IEC (Red, Green, Yellow) ECT Cotton Bite Blocks Size Large ECT Cotton Bite Blocks Size Medium 27 others EEG Green Reference Lead EEG Safety Leads (Brown) EEG Safety Leads (Gray) EEG/EEG Five-Lead Set EMG Safety Leads (Blue) Safety Monitor Cable EEG1/EEG2 Safety Monitor Cable EEG3/EEG4 Sigma Dual Hand-Held Electrode Assembly with Push Button Sigma Dual Hand-Held Electrode Assembly without Push Button Sigma Safety Monitor Cable DOM ECG/EMG Sigma Safety Monitor Cable IEC ECG/EMG Sigma Single Hand-Held Electrode Assembly with Push Button Sigma Single Hand-Held Electrode Assembly without Push Button SigmaStim Sigma 200J SigmaStim Σigma 200J93/42 Two Concave Stimulus Electrodes Two Flat Stimulus Electrodes OMS Cable (no longer marketed) spECTrum Dual Hand-Held w/ Remote (replacement) (no longer marketed) spECTrum Dual Hand-Held w/o Remote (replacement) (no longer marketed) spECTrum EEG/ECG Five-Lead Set (replacement) (no longer marketed) spECTrum EEG/ECG Five-Lead Set-IEC (replacement) (no longer marketed) spECTrum Patient Stimulus Cable (replacement) (no longer marketed) spECTrum Safety Monitor Cable DOM EEG/ECG (replacement) (no longer marketed) spECTrum Safety Monitor Cable IEC EEG/ECG (replacement) (no longer marketed) spECTrum Single Hand-Held w/o Remote (replacement) (no longer marketed) spECTrum Single Hand-Held w/Remote (replacement) (no longer marketed)	I, IIb MDR, 93/42	EUDAMED record Report an error

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