FDA.reportPublic FDA data

Béa Fertility

Primary DI
05065015660002
Brand
Béa Fertility
Company
STEPONE FERTILITY LTD
Model
BAP-GB-01
Device description
Béa Applicator
Published
2025-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
HDRCap, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDRCap, CervicalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242031000Béa Applicator (BAP-GB-01)Stepone Fertility Ltd (T/A Béa Fertility)2025-04-02HDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05065015660002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05065015660002050650156600025065015660002

GMDN Terms#

Term, Definition table
TermDefinition
Conceptive cervical cap, single-useA flexible device designed to promote conception, either by serving as a container to introduce semen into the cervix, or by acting as a cervical cup that allows sperm to be held in place for easier access to the cervical os. It is a plastic device which may have a condom-like sheath for semen collection, and may be supplied with a dedicated applicator. The device is used to aid conception in couples who have experienced difficulties due to low sperm counts, reduced sperm motility or a hostile vaginal environment; and also for self or assisted insemination. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
225808762
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05065015660064Béa FertilityBTK-US-012025-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05065015660064Béa FertilitySTEPONE FERTILITY LTDHDR2025-07-24
00810028774124Frida FertilityFridababy, LLCHDR2023-12-05
03700111400542SMALL GENITOR® INTRA UTERINE INSIMINATION CANNULALABORATOIRE CCDHDR2023-12-05
03700111400559STANDARD INTRA UTERINE INSIMINATION CANNULALABORATOIRE CCDHDR2023-12-05
03700111400566INTRA UTERINE INSEMINATION CANNULA WITH MANDRELLABORATOIRE CCDHDR2023-12-05
03700111400573MEMORY INTRA UTERINE INSIMINATION CANNULALABORATOIRE CCDHDR2023-12-05
03700111400733SPIRETTE®LABORATOIRE CCDHDR2023-12-05
03700111400740MUCAT® STERILELABORATOIRE CCDHDR2023-12-05
10810028774121Frida FertilityFridababy, LLCHDR2023-12-05
03700111425545SMALL GENITOR® INTRA UTERINE INSIMINATION CANNULALABORATOIRE CCDHDR2023-12-05
03700111425552STANDARD INTRA UTERINE INSIMINATION CANNULALABORATOIRE CCDHDR2023-12-05
03700111425569INTRA UTERINE INSEMINATION CANNULA WITH MANDRELLABORATOIRE CCDHDR2023-12-05
03700111425576MEMORY INTRA UTERINE INSIMINATION CANNULALABORATOIRE CCDHDR2023-12-05
03700111425736SPIRETTE®LABORATOIRE CCDHDR2023-12-05
03700111425743MUCAT® STERILELABORATOIRE CCDHDR2023-12-05
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