Data / Medical devices / United Kingdom / B-Secur Limited
B-Secur Limited: FDA-registered device maker in Belfast, United Kingdom, 2 510(k) clearances
B-Secur Limited is registered with the FDA (registration 3031786139) in Belfast, United Kingdom. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 16, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031786139
- Address
- 11th Floor, City Quays 3 92 Donegall Quay, Belfast, United Kingdom, BT1 3FE
- Owner or operator
- B-Secur Limited (10093270)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- April 22, 2025
- Registered through
- 2026
- Brand names listed
- HeartKey® Edge ECG, HeartKey® Rhythm
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Electrocardiograph | DPS | 2 | Complaint file establishment, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| August 16, 2024 | K233755 | HeartKey® Rhythm | DQK | Substantially Equivalent | B-Secur Limited | accessdata.fda.gov |
| December 7, 2020 | K200884 | B-Secur HeartKey Software Library | DPS | Substantially Equivalent | B-Secur , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 16, 2024. 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.