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Newport Medical Instruments, Inc.

USA · Costa Mesa

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Israel — 4 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

23510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 23 510(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

5active device licences

Class II 3Class III 2

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States0 registration records, 23 510(k), 0 PMA, 2 excluded

Brazil1 confirmed, 0 excluded

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: NEWPORT MEDICAL INSTRUMENTS INC. · NEWPORT MEDICAL INSTRUMENTS, INC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K121891	NEWPORT AURA VENTILATOR	2012-11-09
US	K111146	NEWPORT HT70 VENTILATOR	2011-12-01
US	K101803	NEWPORT E360 VENTILATOR	2010-09-08
BR	10349000509	CIRCUITOS E VÁLVULAS REUTILIZÁVEIS PARA VENTILADOR PORTÁTIL	Class II
CA	69650	NEWPORT E500 WAVE VENTILATOR	Class III
CA	35760	HT50 VENTILATOR	Class III
CA	69030	AIR/02 MIXER	Class II

Newport Medical Instruments, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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