B-Secur, Ltd.
United KingdomFDA 510(k) applicant, unverified FDA
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What B-Secur, Ltd. makes
B-Secur, Ltd. develops the HeartKey Software Library, a digital security solution designed to protect and authenticate medical device communications, particularly within cardiac implantable electronic device (CIED) systems.
The company’s portfolio is regulated under FDA’s Class II device classification and is listed via the 510(k) pathway. The manufacturer operates from the United States.
Catalogue
HeartKey® Rhythm Ref K233755
510(k) 510(k)B-Secur HeartKey Software Library Ref K200884
510(k) 510(k)
FDA establishments
- B-Secur Limited Belfast · GB FEI 3031786139
Frequently asked questions
How many devices does B-Secur, Ltd. have in the registry?
The registry currently lists 2 devices for B-Secur, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list B-Secur, Ltd.'s devices?
Among its 2 most recently registered devices, B-Secur, Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do B-Secur, Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for B-Secur, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from B-Secur, Ltd. in the registry?
The most recently registered devices listed for B-Secur, Ltd. include HeartKey® Rhythm and B-Secur HeartKey Software Library.
Which FDA establishments are linked to B-Secur, Ltd.?
1 FDA establishment is linked to B-Secur, Ltd. in the registry; they are listed on the company page.