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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 6 of 9

Device	Model / Reference	Registries	Class	Status
Natus Neurology	X1F012	FDA UDI	Class II	Active
Natus	019-476600	FDA UDI	Class II	Unknown
Natus	019-427000	FDA UDI	Class II	Active
Natus	515-005800	FDA UDI	Class II	Active
Natus Neurology	019-474900	FDA UDI	Class II	Active
Natus	019-425900	FDA UDI	Class II	Active
Natus	515-014600	FDA UDI	Class II	Active
Natus	019-477500	FDA UDI	Class II	Unknown
Natus	515-013400	FDA UDI	Class II	Active
Natus Neurology	672-106100	FDA UDI	Class II	Active
Natus	019-475100	FDA UDI	Class II	Active
Natus	515-006200	FDA UDI	Class II	Active
Natus	019-478600	FDA UDI	Class II	Unknown
Natus Neurology	TV180	FDA UDI	Class II	Active
Natus Neurology	842-507500	FDA UDI	Class II	Active
Natus	019-478500	FDA UDI	Class II	Unknown
Natus	482-647500	FDA UDI	Class II	Active
Natus Neurology	031C001	FDA UDI	Class II	Active
Natus Neurology	DM-515-010300	FDA UDI	Class II	Active
Natus Neurology	XVLB02	FDA UDI	Class II	Active
Natus Neurology	713-413300F	FDA UDI	Class II	Active
Natus	040C001	FDA UDI	Class II	Active
Natus Neurology	XPA002	FDA UDI	Class II	Active
Natus	019-479000	FDA UDI	Class II	Unknown
Natus Neurology	842-689500	FDA UDI	Class II	Active
Natus	222-515100	FDA UDI	Class II	Active
Natus	040K011	FDA UDI	Class II	Active
Component Neuromonitoring System	CNS-PTZ-350	FDA UDI	Class II	Active
Natus	019-477000	FDA UDI	Class II	Unknown
CNS Envision	1.03.00	FDA UDI	Class II	Active
Natus Temperature Probe Adapter	043311	EUDAMED	Class IIb	Active
EMG Electrodes and Accessories	019-401400	EUDAMEDFDA UDI	Class I	Active
Ancillary EMG, EEG &/or IOM Cables	019-417000	EUDAMEDFDA UDI	Class I	Active
EDX HB7 Head Box 0127	515-012700	EUDAMEDFDA UDI	Class IIb	Active
Reusable Cup Electrodes	019-772500	EUDAMEDFDA UDI	Class I	Active
Adhesive Electrodes	019-422200	EUDAMEDFDA UDI	Class I	Active
RS10 Comfort Probe Kit	515-016300	EUDAMEDFDA UDI	Class I	Active
UltraPro S100 Laptop Win PC, German	842-695400DE	EUDAMED	Class IIb	Active
RS10 Comfort Probe Kit	515-016400	EUDAMEDFDA UDI	Class I	Active
Adhesive Electrodes	019-420800	EUDAMEDFDA UDI	Class I	Active
Reusable Cup Electrodes	019-413900	EUDAMEDFDA UDI	Class I	Active
Software Update to v22.3	688-628600	EUDAMEDFDA UDI	Class IIb	Active
Ancillary EMG, EEG &/or IOM Cables	117-401900	EUDAMEDFDA UDI	Class I	Active
Natus Elite v2 Software Upgrade with New System Order	688-630200	EUDAMEDFDA UDI	Class IIb	Active
EDX 4 channel Amplifier	842-691900	EUDAMEDFDA UDI	Class IIb	Active
2015 Visual Stimulator Only	842-647900	EUDAMEDFDA UDI	Class IIb	Active
Natus Elite v2 Reader Software	828-080000	EUDAMEDFDA UDI	Class IIb	Active
Adhesive Electrodes	443020	EUDAMEDFDA UDI	Class I	Active
Nicolet LED Goggles	842-106504	EUDAMEDFDA UDI	Class I	Active
RS10 Comfort Probe Kit	071-423800	EUDAMEDFDA UDI	Class I	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.