SigmaStim Domestic LLC - Manufacturer Profile

Explore comprehensive manufacturer profile for SigmaStim Domestic LLC through Pure Global AI's free EU medical device database. This company manufactures 46 medical devices registered with EUDAMED across 2 risk classes based in United States.

This page provides detailed insights including recent registrations, risk class distribution (Class IIb: 1, Class I: 45), and complete regulatory information from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry.

Free Manufacturer Profile

46 Devices

2 Risk Classes

SigmaStim Domestic LLC

Manufacturer - United States

Total Devices

Risk Classes

2022

Earliest Version

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Recent Products (Latest 10)

Most recently updated devices in the database

Device Name	Risk Class	Detail
spECTrum Safety Monitor Cable IEC EEG/ECG (replacement)	Class I
spECTrum Dual Hand-Held w/o Remote (replacement)	Class I
spECTrum EEG/ECG Five-Lead Set (replacement)	Class I
spECTrum EEG/ECG Five-Lead Set-IEC (replacement)	Class I
spECTrum Single Hand-Held w/o Remote (replacement)	Class I
spECTrum EMR Software (replacement)	Class I
spECTrum Dual Hand-Held w/ Remote (replacement)	Class I
spECTrum Single Hand-Held w/Remote (replacement)	Class I
spECTrum Patient Stimulus Cable (replacement)	Class I
spECTrum Safety Monitor Cable DOM EEG/ECG (replacement)	Class I

Risk Class Distribution

Breakdown by risk classification

Class I

45(97.8%)

Class IIb

1(2.2%)

Top Authorized Representatives

Most common authorized representatives for this manufacturer

Authorized Representative	Device Count	Percentage	View
ICON (LR) Limited	46	100.0%