Is this your brand? Sign in to claim ownership.

Natus Neurology Incorporated

United States·US-MF-000004246

Last updated September 17, 2026

Information

Country: United States
Address: 3150, Pleasant View Road , Middleton, Wisconsin , United States
Website: natus.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 905 287 5055
PRRC Contact: Sanjay Mehta
EUDAMED SRN: US-MF-000004246
FDA FEI Number: 3010611950
DUNS Number: —

Catalogue (443)

Page 8 of 9

Device	Model / Reference	Registries	Class	Status
Upgrade from Keypoint.NET to Natus Elite - Keypoint Master Software	688-630150	EUDAMED	Class IIb	Active
Snap Electrodes & Lead Cables	019-419300	EUDAMEDFDA UDI	Class I	Active
Cortical Stimulator Control Unit	515-005500	EUDAMEDFDA UDI	Class IIb	Active
Natus Elite v2 Software - Viking	828-080200	EUDAMEDFDA UDI	Class IIb	Active
RS10 Comfort Probe Kit	071-423500	EUDAMEDFDA UDI	Class I	Active
Stimulus Switching Pod SP1	515-020400	EUDAMEDFDA UDI	Class IIb	Active
Adhesive Electrodes	019-400500	EUDAMEDFDA UDI	Class I	Active
EDX Laptop PC, German	842-689900DE	EUDAMED	Class IIb	Active
Viking EDX International	982A0568	EUDAMED	Class IIb	Active
EMG Electrodes and Accessories	5032-TP	EUDAMEDFDA UDI	Class I	Active
EMG USB Control Panel II	043281	EUDAMEDFDA UDI	Class IIb	Active
Natus Elite EMG v22.4.1 Install Media	482-652000U	EUDAMEDFDA UDI	Class IIb	Active
Reusable Cup Electrodes	019-772600	EUDAMEDFDA UDI	Class I	Active
Ancillary EMG, EEG &/or IOM Cables	019-420100	EUDAMEDFDA UDI	Class I	Active
Ancillary EMG, EEG &/or IOM Cables	CB0102	EUDAMEDFDA UDI	Class I	Active
EDX 2 channel Amplifier	515-016000	EUDAMEDFDA UDI	Class IIb	Active
Ancillary EMG, EEG &/or IOM Cables	019-433000	EUDAMEDFDA UDI	Class I	Active
Adhesive Electrodes	019-415200	EUDAMEDFDA UDI	Class I	Active
Nicolet Shielded 300 ohm Headphone (TDH39)	842-202300	EUDAMEDFDA UDI	Class I	Active
Natus Elite - Synergy & Viking Combo Master Software	828-069500	EUDAMEDFDA UDI	Class IIb	Active
Nicolet Shielded 300 ohm Headphone (TDH39)	842-202700	EUDAMEDFDA UDI	Class I	Active
RS10 Comfort Probe Kit	515-018800	EUDAMEDFDA UDI	Class I	Active
Natus Elite v2 Software - Synergy & Viking Combo	828-080300	EUDAMEDFDA UDI	Class IIb	Active
Adhesive Electrodes	019-435500	EUDAMEDFDA UDI	Class I	Active
Adhesive Electrodes	019-768500	EUDAMEDFDA UDI	Class I	Active
UltraPro UB3 Cart	022330	EUDAMEDFDA UDI	Class I	Active
Natus Elite v2 Software - Synergy	828-080100	EUDAMEDFDA UDI	Class IIb	Active
Adhesive Electrodes	454010	EUDAMEDFDA UDI	Class I	Active
Nicolet EDX Amplifier Cables	085-477100	EUDAMEDFDA UDI	Class I	Active
EDX 2 channel Amplifier	515-015100	EUDAMEDFDA UDI	Class IIb	Active
Reusable Cup Electrodes	019-414100	EUDAMEDFDA UDI	Class I	Active
Snap Electrodes & Lead Cables	019-429400	EUDAMEDFDA UDI	Class I	Active
EDX HB7 Head Box	515-016600	EUDAMEDFDA UDI	Class IIb	Active
Natus Elite v2 Software Update	688-630000	EUDAMEDFDA UDI	Class IIb	Active
EDX 7 channel Amplifier	842-692200	EUDAMEDFDA UDI	Class IIb	Active
Reusable Cup Electrodes	019-417700	EUDAMEDFDA UDI	Class I	Active
EDX 6 channel Amplifier	842-692100	EUDAMEDFDA UDI	Class IIb	Active
Reusable Cup Electrodes	019-772200	EUDAMEDFDA UDI	Class I	Active
Adhesive Electrodes	N6003	EUDAMEDFDA UDI	Class I	Active
RS10 Comfort Probe Kit	071-422900	EUDAMEDFDA UDI	Class I	Active
Viking EDX Control Panel	842-689400	EUDAMEDFDA UDI	Class IIb	Active
EMG Electrodes and Accessories	019-406700	EUDAMEDFDA UDI	Class I	Active
2015 Visual Stimulator with LCD Monitor	842-648300	EUDAMEDFDA UDI	Class IIb	Active
Adhesive Electrodes	454030	EUDAMEDFDA UDI	Class I	Active
Reusable Cup Electrodes	019-433800	EUDAMEDFDA UDI	Class I	Active
Ancillary EMG, EEG &/or IOM Cables	019-401100	EUDAMEDFDA UDI	Class I	Active
Nicolet EEG Patient Event Button	085-462401	EUDAMEDFDA UDI	Class I	Active
EMG Electrodes and Accessories	019-446700	EUDAMEDFDA UDI	Class I	Active
Adhesive Electrodes	019-400400	EUDAMEDFDA UDI	Class I	Active
Natus Visual Stimulator	043312	EUDAMED	Class IIb	Active

Related Companies

Authorised Representatives

Natus Manufacturing Ltd IE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 27, 2013	Z-0946-2013	—	terminated	Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become uncomfortable to touch around the area of the on/off button. The overheating may result in discomfort ranging from too hot up to the potential for a burn.