FDA.reportPublic FDA data

femSense Fertility

Primary DI
09120095900793
Brand
femSense Fertility
Company
SteadySense GmbH
Model
1
Device description
femSense Fertility is an information system intended for women in their fertile phase delivering information about the fertility status. femSense Fertility provides the probability of the fertility of a user each day.
Published
2026-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LHDDevice, Fertility Diagnostic, Proceptive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHDDevice, Fertility Diagnostic, ProceptiveUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09120095900793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120095900793091200959007939120095900793

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00

Regulatory Flags#

DUNS number
300492871
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09120095900816SteadyTemp12026-11-03
09120095900823SteadyTemp12026-11-03
09120095900274femSense Ovulation Tracker12022-10-26
09120095900021femSense Fertility12021-07-15
09120095900014femSense Kinderwunsch12021-05-17
09120095900281SteadyTemp12024-07-15
09120095900809SteadyTemp12026-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06430060159860Fertile WindowOuraring Inc.LHD2025-11-14
06430060159877Fertile WindowOuraring Inc.LHD2025-11-14
06430060159983Fertile WindowOuraring Inc.LHD2024-11-12
00194253312512Cycle Tracking 4.0APPLE INC.LHD2024-11-01
00194253312529Cycle Tracking 4.0APPLE INC.LHD2024-11-01
06430060159990Fertile WindowOuraring Inc.LHD2024-10-28
04260749840039Clue AppBioWink GmbHLHD2023-07-27
04260749840046Clue AppBioWink GmbHLHD2023-07-27
04260749840022Clue ConceiveBioWink GmbHLHD2023-05-14
04260749840015Clue ConceiveBioWink GmbHLHD2023-05-14
07350014630100Cycle TrackingNaturalcycles Nordic ABLHD2023-04-19
07629999054073DaysyValley Electronics AGLHD2022-12-07
07629999894334Lady-CompValley Electronics AGLHD2022-12-07
09120095900274femSense Ovulation TrackerSteadySense GmbHLHD2022-10-26
07640184680464Ava FertilityAVA Sciences-FMTC GmbHLHD2022-09-29
07640184680136Ava FertilityAVA Sciences-FMTC GmbHLHD2022-09-21
00194252845967Cycle Tracking 3.0APPLE INC.LHD2022-07-27
00194252845974Cycle Tracking 3.0APPLE INC.LHD2022-07-27
00850003500478BeurerBEURER NORTH AMERICA, L.P.LHD2021-10-01
05060508530107OvuSenseVIO HEALTHTECH LIMITEDLHD2021-07-23
05060508530114OvuSenseVIO HEALTHTECH LIMITEDLHD2021-07-23
09120095900021femSense FertilitySteadySense GmbHLHD2021-07-15
06938444982498OT80-Beurer Ovulation Predictor and Fertility Tracking KitEquinox Biotech Co., Ltd.LHD2021-06-30
09120095900014femSense KinderwunschSteadySense GmbHLHD2021-05-17
05060508530091OvuSenseVIO HEALTHTECH LIMITEDLHD2021-05-01
05060508530121OvuSenseVIO HEALTHTECH LIMITEDLHD2021-05-01
00850003500560OVY by BeurerBEURER NORTH AMERICA, L.P.LHD2020-06-01
00850003500430BeurerBEURER NORTH AMERICA, L.P.LHD2019-12-09
20850003500434BeurerBEURER NORTH AMERICA, L.P.LHD2019-12-09
07290016672183Tyto DeviceTYTO CARE LTDLHD2019-01-24