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Neurotronics, LLC

United States·US-MF-000030839

Last updated September 17, 2026

Information

Country: United States
Address: 13800, Tech City Circle, Suite 400, Alachua, United States
Website: www.neurotronics.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 (352) 372-9955
PRRC Contact: James Smith
EUDAMED SRN: US-MF-000030839
FDA FEI Number: 3002459124
DUNS Number: 036405363

Catalogue (63)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
NomadAir PMU810 RIP Belt, Small	PMU810	FDA UDI	Class II	Active
Live View Panel Version 1.3	1.3	FDA UDI	Class II	Unknown
Live View Panel Pro Version 2.0	2.0	FDA UDI	Class II	Active
Echo Polysomnography Playback Unit	ECHO320	FDA UDI	Class I	Unknown
NomadAir PMU810 Portable Recorder	PMU810	FDA UDI	Class II	Active
Polysmith Version 11.0	11.0	FDA UDI	Class II	Active
Sphinx PMU700 Polysomnography Monitoring Unit	PMU700	FDA UDI	Class II	Unknown
NomadAir PMU810 RIP Belt, Medium	PMU810	FDA UDI	Class II	Active
USB DC Box	USBDC100	FDA UDI	Class II	Active
Nomad PMU800 Portable Recorder	PMU800	FDA UDI	Class II	Unknown
NomadAir PMU810 RIP Belt, Large	PMU810	FDA UDI	Class II	Active
Nomad PMU800 Portable Recorder (USB)	PMU800	FDA UDI	Class II	Active
Polysmith Version 10.0	10.0	FDA UDI	Class II	Active
Live View Panel Version 1.4	1.4	FDA UDI	Class II	Active
Polysmith Version 9.0	9.0	FDA UDI	Class II	Unknown
Polysmith 12.0	PS12.0	EUDAMEDFDA UDI	Class IIa	Active
RIP01 RIP Sensor	S53107	EUDAMEDFDA UDI	Class I	Active
Polysmith Sleep System	K142774	FDA 510(k)	Class II	Active
Nomad Sleep System Recorder, Model Pmu800	K092699	FDA 510(k)	Class II	Active
NomadAir PMU810	K220631	FDA 510(k)	Class II	Active
Polysmith Sleep System, Model Nti5498	K062943	FDA 510(k)	Class II	Active
Live View Panel (lvp)	K131415	FDA 510(k)	Class II	Active
Serenity Body Position Sensor, Serenity RIP Sensors	K173868	FDA 510(k)	Class II	Active
Serenity Piezo Sensor, Serenity Thermocouple Sensor	K181709	FDA 510(k)	Class II	Active
PV01 PVDF Effort Sensor	K251480	FDA 510(k)	Class II	Active
Polysmith Sleep System, Model NTI7593	K161650	FDA 510(k)	Class II	Active
Neurotronics Polysomnography System 101	K971803	FDA 510(k)	Class II	Active
RIP01 RIP Sensor	S13421	EUDAMEDFDA UDI	Class I	Active
TH01 Thermocouple Sensor	S60012	EUDAMEDFDA UDI	Class I	Active
TH01 Thermocouple Sensor	S47581	EUDAMEDFDA UDI	Class I	Active
RIP01 RIP Sensor	S33059	EUDAMEDFDA UDI	Class I	Active
TH01 Thermocouple Sensor	S29604	EUDAMEDFDA UDI	Class I	Active
TH01 Thermocouple Sensor	S40050	EUDAMEDFDA UDI	Class I	Active
BP01 Body Position Sensor	S17926	EUDAMEDFDA UDI	Class I	Active
BP01 Body Position Sensor	S40712	EUDAMEDFDA UDI	Class I	Active
RIP01 RIP Sensor	S77038	EUDAMEDFDA UDI	Class I	Active
PZ01 Piezo Sensor	S60780	EUDAMEDFDA UDI	Class I	Active
TH01 Thermocouple Sensor	S28085	EUDAMEDFDA UDI	Class I	Active
PZ01 Piezo Sensor	S77350	EUDAMEDFDA UDI	Class I	Active
PZ01 Piezo Sensor	S83111	EUDAMEDFDA UDI	Class I	Active
TH01 Thermocouple Sensor	S58317	EUDAMEDFDA UDI	Class I	Active
RIP01 RIP Sensor	S75163	EUDAMEDFDA UDI	Class I	Active
PZ01 Piezo Sensor	S52897	EUDAMEDFDA UDI	Class I	Active
TH01 Thermocouple Sensor	S15302	EUDAMEDFDA UDI	Class I	Active
TH01 Thermocouple Sensor	S21109	EUDAMEDFDA UDI	Class I	Active
RIP01 RIP Sensor	S55638	EUDAMEDFDA UDI	Class I	Active
TH01 Thermocouple Sensor	S53260	EUDAMEDFDA UDI	Class I	Active
PZ01 Piezo Sensor	S61060	EUDAMEDFDA UDI	Class I	Active
RIP01 RIP Sensor	S39154	EUDAMEDFDA UDI	Class I	Active
Sphinx CU710 Control Unit	CU710	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

NIHON KOHDEN EUROPE GmbH DE

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