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iHealth Labs, Inc.

USA · Sunnyvale

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Singapore — 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

5listed device types

Class I 1Class II 4Class III 0

plus 1 registration records and 4 510(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

3active device licences

Class II 3

7 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

7device registrations

CLASS B 5CLASS C 2

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 States1 registration records, 4 510(k), 0 PMA, 1 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: iHealth Labs, Inc. · IHEALTH LABS INC.

FDA 510(k) clearances by year

12024 · K233842

32025 · K251085

FDA listed device types

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Analyzer, Body Composition, Exempt 1Oximeter, Infrared, Sporting, Aviation 1System, Measurement, Blood-Pressure, Non-Invasive 1Medical Device Data System 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251085	iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro	2025-12-12
US	K251092	iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro	2025-12-12
US	K243146	iCare APP	2025-02-03
CA	90006	IHEALTH WIRELESS BLOOD PRESSURE MONITOR	Class II
CA	90050	IHEALTH WIRELESS BLOOD PRESSURE WRIST MONITOR	Class II
CA	100256	IHEALTH NON-CONTACT INFRARED THERMOMETER	Class II

iHealth Labs, 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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