Home›Canada›CARDIOCOMM SOLUTIONS, INC.

CARDIOCOMM SOLUTIONS, INC.

Canada · Toronto

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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 0Class II 3Class III 0

plus 10 registration records and 9 510(k)

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 II 1

6 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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 States10 registration records, 9 510(k), 0 PMA

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: CARDIOCOMM SOLUTIONS, INC.

FDA 510(k) clearances by year

32002 · K022297

12003 · K033037

22011 · K111159

12012 · K121009

12014 · K122632

12019 · K181310

FDA listed device types

Electrocardiograph 1Recorder, Magnetic Tape, Medical 1Transmitters And Receivers, Electrocardiograph, Telephone 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K181310	HeartCheck Cardi Beat ECG Monitor with GEMS Mobile	2019-02-22
US	K122632	GUAVA II	2014-02-11
US	K121009	HEARTCHECK ECG PEN WITH GEMS HOME	2012-05-17
CA	103542	GEMS SIRONA	Class II

CARDIOCOMM SOLUTIONS, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies