Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031786139

FEI Number

3031786139

Entity Name

B-SECUR LIMITED

City/State/Country

Belfast, GB

Establishment Address

11th Floor, City Quays 3, 92 Donegall Quay, Belfast BT1 3FE, GB

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

B-Secur Limited (Owner Number: 10093270)

Owner / Operator Contact Address

11th Floor, City Quays 3, 92 Donegall Quay, Belfast, GB-BFS BT1 3FE, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233755

PMA Number

N/A

All Registered Proprietary Names

HeartKey® Edge ECG HeartKey® Rhythm

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2025-04-22
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2025-04-22
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2025-04-22
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2025-04-22

Official Correspondent

Cameron Moore

US Agent Details

Prabhu Raghavan Business: MDQR LLC Email: info@mdqr.solutions Phone: (408) 3165707

Related Public Records

Same Entity

B-Secur Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935043	Siemens Medical Electronics	SIEMENS CLINICAL WORK STATION	1995-04-07
K170948	Acutus Medical, Inc.	AcQMap High Resolution Imaging and Mapping System	2017-10-16
K242016	ABBOTT MEDICAL	EnSite X EP System	2024-08-09
K172182	St. Jude Medical (Now Part of the Abbott Medical)	QUANTIEN Measurement System	2017-08-18
K252013	ABBOTT MEDICAL	EnSite X EP System	2025-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Z-0034-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Z-0035-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

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3013300026	BIOSENSE WEBSTER, INC.	Irvine, CA, US
3003084417	STEREOTAXIS, INC.	Saint Louis, MO, US
3026523691	RHYTHM AI INC	La Jolla, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031786139. Last updated year: 2026. Please use registration number 3031786139 when referencing this establishment in official correspondence.