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Heartsine Technologies, Inc.

United Kingdom of Great Britain and Northern Ireland · Belfast

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 9 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

3listed device types

Class I 1Class II 0Class III 2

plus 2 registration records and 6 510(k), 33 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

1active device licences

Class III 1

5 including historic records

TWTaiwanTFDA

2valid device licences

Class III 2

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

7active ARTG entries

Class III 3IIb 4

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 2b 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States2 registration records, 6 510(k), 33 PMA

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: HEARTSINE TECHNOLOGIES, LTD · HEARTSINE TECHNOLOGIES, LTD.

Business registration

Legal name: HEARTSINE TECHNOLOGIES LIMITED
Company number: NI034331
Registration status: Active
Legal form: Private Limited Company
Incorporated: 1998-06-10
Principal activity: 26600 - Manufacture of irradiation, electromedical and electrotherapeutic equipment
Registered address: 207 AIRPORT ROAD WEST, BELFAST, BT3 9ED

Business registration data from UK Companies House, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12003 · K023854

22004 · K042088

12006 · K052465

12013 · K123881

12015 · K142709

FDA listed device types

Automated External Defibrillators (Non-Wearable) 1Over-The-Counter Automated External Defibrillator 1Medical Device Data System 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K142709	samaritan PAD 450P	2015-03-27
US	K123881	HEARTSINE SAMARITAN PAD 350P	2013-07-11
US	K052465	REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351	2006-12-12
CA	67532	SAMARITAN PAD AUTOMATED EXTERNAL DEFIBRILLATOR	Class III