Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006258337

FEI Number

3006258337

Entity Name

SOMNOMEDICS AG

City/State/Country

RANDERSACKER Bavaria, DE

Establishment Address

AM SONNENSTUHL 63, RANDERSACKER Bavaria 97236, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SOMNOmedics AG (Owner Number: 9084423)

Owner / Operator Contact Address

AM SONNENSTUHL 63, RANDERSACKER, DE-NOTA 97236, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231104

PMA Number

N/A

All Registered Proprietary Names

HomeSleepTest (HST, HST REM+) EEG-acp Somnoscreen EEG 10-20 SOMNOscreen HD SOMNOscreen Eco SomnoScreen Plus SOMNOtouch RESP SOMNOtouch PSG SOMNOtouch RESP eco SomnoWatch ABPMpro Ambulatory Blood Pressure Recorder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2024-12-12
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2024-12-12
GYB	Media, Electroconductive	Neurology	Class 2	882.1275	2022-11-08
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2008-01-10
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2015-02-13
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2008-12-31
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2023-11-28
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-11-28

Official Correspondent

No official correspondent registered.

US Agent Details

Cherita James Business: Pro Pharma Group Email: cherita.james@propharmagroup.com Phone: (347) 9540624

Related Public Records

Same Entity

SOMNOmedics AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K082968	Apneicare, LLC	APNEICARE CONNECTION CENTER/INTERNET ANALYSIS	2009-01-02
K161650	Neurotronics, Inc.	Polysmith Sleep System, Model NTI7593	2017-01-19
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2022	NOX MEDICAL Keldnaholt Reykjavik Iceland	2	Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006258337. Last updated year: 2026. Please use registration number 3006258337 when referencing this establishment in official correspondence.