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Etiometry, Inc.

USA · Dedham

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

4listed device types

Class I 1Class II 3Class III 0

plus 7 registration records and 11 510(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

2active device licences

Class II 2

3 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 States7 registration records, 11 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: ETIOMETRY INC.

FDA 510(k) clearances by year

22015

12016

12017

12019

12020

12022

22023

12025

12026

FDA listed device types

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Adjunctive Cardiovascular Status Indicator 1Multivariate Vital Signs Index 1Medical Device Data System 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254066	Etiometry Platform	2026-04-03
US	K241479	Etiometry Platform (DAV 5.4 RAE 9.2)	2025-02-12
US	K223578	T3 Platform software	2023-07-07
BR	81915610003	Etiometry Platform Software	Class II
CA	106088	T3 PLATFORM SOFTWARE	Class II
CA	107712	ETIOMETRY PLATFORM SOFTWARE	Class II

Etiometry, 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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