STEPONE FERTILITY LTD

FDA Device Registration & Listing · London Westminster, GB · Registration 3038597712

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3038597712
FEI Number
3038597712
Entity Name
STEPONE FERTILITY LTD
City/State/Country
London Westminster, GB
Establishment Address
WeWork 123 Buckingham Palace Rd, London Westminster SW1W 9SH, GB
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
StepOne Fertility Ltd (Owner Number: 10093574)
Owner / Operator Contact Address
WeWork 123 Buckingham Palace Rd, London, GB-LND SW1W 9SH, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K242031
PMA Number
N/A

All Registered Proprietary Names

Bea Applicator Bea Treatment Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2025-06-05
HDR Cap, Cervical Obstetrics/Gynecology Class 2 884.5250 2025-06-05
OBB Kit, Conception-Assist, Home Use Obstetrics/Gynecology Class 2 884.5250 2025-06-05

Official Correspondent

No official correspondent registered.

US Agent Details

Tess Cosad Email: tess@beafertility.com Phone: (929) 9093604

Related Public Records

Same Entity

StepOne Fertility Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038597712. Last updated year: 2026. Please use registration number 3038597712 when referencing this establishment in official correspondence.
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