Data / Medical devices / Germany / Somnomedics AG

Somnomedics AG: FDA-registered device maker in RANDERSACKER Bavaria, Germany, 8 510(k) clearances

Name: Somnomedics AG FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Somnomedics AG is registered with the FDA (registration 3006258337) in RANDERSACKER Bavaria, Germany. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated December 8, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006258337
Address: Am Sonnenstuhl 63, RANDERSACKER Bavaria, Germany, 97236
Owner or operator: SOMNOmedics AG (9084423)
Roles: Manufacturer, Specification developer
First device listed: March 13, 2007
Registered through: 2026
Brand names listed: ABPMpro Ambulatory Blood Pressure Recorder, EEG-acp, HomeSleepTest (HST, HST REM+), SOMNO SCREEN, SOMNOscreen Eco, SOMNOscreen HD, SOMNOtouch PSG, SOMNOtouch RESP and more

Devices it lists

Device	Product code	Class	Role	Source
Media, Electroconductive	GYB	2	Specification developer	accessdata.fda.gov
Recorder, Magnetic Tape, Medical	DSH	2	Manufacturer	accessdata.fda.gov
Standard Polysomnograph With Electroencephalograph	OLV	2	Manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Manufacturer	accessdata.fda.gov
Ventilatory Effort Recorder	MNR	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 8, 2024	K240700	HomeSleepTest (HST, HST REM+)	OLV	Substantially Equivalent	Somnomedics GmbH	accessdata.fda.gov
November 27, 2023	K231104	ABPMpro	DSH	Substantially Equivalent	Somnomedics GmbH	accessdata.fda.gov
June 15, 2022	K212325	EEG-acp	GYB	Substantially Equivalent	Somnomedics GmbH	accessdata.fda.gov
August 12, 2020	K201054	SOMNOscreen plus	OLV	Substantially Equivalent	Somnomedics GmbH	accessdata.fda.gov
January 30, 2015	K140861	SOMNOTOUCH RESP	MNR	Substantially Equivalent	Somnomedics GmbH	accessdata.fda.gov
September 18, 2008	K081485	SOMNOWATCH	MNR	Substantially Equivalent	Somnomedics GmbH	accessdata.fda.gov
July 18, 2007	K071556	SOMNOSCREEN EEG10-20	MNR	Substantially Equivalent	Somnomedics GmbH	accessdata.fda.gov
January 24, 2007	K060708	SOMNOSCREEN	MNR	Substantially Equivalent	Somnomedics GmbH & Co. KG	accessdata.fda.gov

Compare with other makers

Updated December 8, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.