FDA.reportPublic FDA data

Clue Conceive

Primary DI
04260749840022
Brand
Clue Conceive
Company
BioWink GmbH
Model
Android
Device description
Clue Conceive is a mode of the Clue app. Clue Conceive's proprietary algorithm uses period start date information entered by the user to provide predictions on the best days to try and conceive. Identification of high chance days allows the user to determine the days on which their chance of conception is highest, and then make choices about when to have sex to increase chance of pregnancy.
Published
2023-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04260749840022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260749840022042607498400224260749840022

GMDN Terms#

Term, Definition table
TermDefinition
Self-care monitoring/reporting softwareAn application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional, and/or exercise information in the home, which may include medication administration information captured from enabled injection devices and data from wearable devices, providing care plan, journal, medication advice, and/or messaging functionalities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
342751189
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260749840039Clue AppiOS2023-07-27
04260749840046Clue AppAndroid2023-07-27
04260749840008Clue Birth Control12022-04-08
04260749840015Clue ConceiveiOS2023-05-14

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
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
07290016672213TytoHomeTYTO CARE LTDLHD2019-01-24