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Eko Health, Inc.

USA · Emeryville

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia — 5 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

5listed device types

Class I 1Class II 4Class III 0

plus 9 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

IIa 4

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 States9 registration records, 4 510(k), 0 PMA, 4 excluded

Brazil1 confirmed, 2 excluded

Canada1 confirmed, 1 excluded

Manufacturer names merged into this page: Eko Health, Inc. · EKO HEALTH, INC.

FDA 510(k) clearances by year

22024 · K233609

12025 · K251494

12026 · K261694

FDA listed device types

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Electrocardiograph 1Reduced Ejection Fraction Machine Learning-Based Notification Software 1Stethoscope, Electronic 1Phonocardiograph 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261694	CORE 300 Digital Stethoscope	2026-07-23
US	K251494	Eko Foundation Analysis Software with Transformers (EFAST)	2025-08-12
US	K233609	CORE 500 Digital Stethoscope	2024-03-28
BR	80284939139	Estetoscópio digital 3M Littmann CORE	Class II
CA	104403	EKO DUO	Class II

Eko Health, 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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