Data / Medical devices / United Kingdom / Stepone Fertility Ltd
Stepone Fertility Ltd: FDA-registered device maker in London Westminster, United Kingdom, 1 510(k) clearance
Stepone Fertility Ltd is registered with the FDA (registration 3038597712) in London Westminster, United Kingdom. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 2, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038597712
- Address
- WeWork 123 Buckingham Palace Rd, London Westminster, United Kingdom, SW1W 9SH
- Owner or operator
- StepOne Fertility Ltd (10093574)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- June 5, 2025
- Registered through
- 2026
- Brand names listed
- Bea Applicator, Bea Treatment Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cap, Cervical | HDR | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Kit, Conception-Assist, Home Use | OBB | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 2, 2025 | K242031 | Béa Applicator (BAP-GB-01) | HDR | Substantially Equivalent | Stepone Fertility Ltd (T/A Béa Fertility) | accessdata.fda.gov |
Compare with other makers
Updated April 2, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.