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AliveCor, Inc.

USA · Mountain View

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Hong Kong, Israel — 7 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

7listed device types

Class I 1Class II 6Class III 0

plus 20 registration records and 19 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

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

0active device licences

4 including historic records

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

IIa 4IIb 1

HKHong KongMDACS

2valid listings

Class II 1Class III 1

ILIsraelAMAR

3registrations

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 States20 registration records, 19 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: AliveCor · ALIVECOR, INC.

FDA 510(k) clearances by year

12012

12013

32014

12015

12017

32019

22020

22021

22022

22024

12026

FDA listed device types

Transmitters And Receivers, Electrocardiograph, Telephone 1Electrocardiograph 1Electrocardiograph Software For Over-The-Counter Use 1Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) 1Computer, Diagnostic, Programmable 1Stethoscope, Electronic 1Medical Device Data System 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252589	Corvair Monza	2026-01-09
US	K232035	Impala	2024-06-07
US	K231010	Corvair	2024-06-07
BR	81952079006	KardiaMobile 6L	Class II
BR	81952070023	KardiaStation	Class II
BR	81952070019	kardia app	Class II

AliveCor, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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