Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016866092

FEI Number

3016866092

Entity Name

STEADYSENSE GMBH

City/State/Country

Raaba-Grambach Steiermark, AT

Establishment Address

Johann-Schreiner-Strase 3, Raaba-Grambach Steiermark 8074, AT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SteadySense GmbH (Owner Number: 10073696)

Owner / Operator Contact Address

Johann-Schreiner-Strsse 3, Raaba-Grmbach, AT-6 8074, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233280

PMA Number

N/A

All Registered Proprietary Names

femSense Kinderwunsch femSense Fertility femSense Ovulation Tracker SteadyTemp

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LHD	Device, Fertility Diagnostic, Proceptive	Unknown	Class U	N/A	2020-05-13
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-07-08

Official Correspondent

Werner Koele

US Agent Details

Peter Hasslacher Email: newyork@wko.at Phone: (212) 4215250

Related Public Records

Same Entity

SteadySense GmbH

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
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

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3014848805	NATURALCYCLES NORDIC AB	Stockholm, SE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016866092. Last updated year: 2026. Please use registration number 3016866092 when referencing this establishment in official correspondence.