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WESTMED, INC.

USA · Tucson

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, Australia, Israel, Russia — 8 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

46listed device types

Class I 26Class II 20Class III 0

plus 64 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 2

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

4registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

13active device licences

Class II 13

24 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

IVD Class 1 1IIa 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 States64 registration records, 8 510(k), 0 PMA, 4 excluded

Brazil2 confirmed, 0 excluded

Saudi Arabia4 confirmed, 0 excluded

Canada13 confirmed, 0 excluded

Manufacturer names merged into this page: WESTMED, INC. · WESTMED, INC · Westmed Inc.

FDA 510(k) clearances by year

11995

22007

12008

12012

12014

12015

12016

FDA listed device types

showing 8 of 46

Anesthesia Breathing Circuit Kit (Adult & Pediatric) 1Mouthpiece, Breathing 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Mask, Oxygen, Non-Rebreathing 1Arterial Blood Sampling Kit 1Mask, Gas, Anesthetic 1Splint, Intranasal Septal 1Connector, Airway (Extension) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K162343	Westmed Gas Sampling Cannula with O2 delivery	2016-12-14
US	K143148	Disposable Pressure Manometer (DPM)	2015-08-11
US	K133057	VIBRALUNG ACOUSTICAL PERCUSSOR	2014-05-23
BR	80788620050	SERINGA DE GASES	Class I
BR	10290310078	Seringa para Gasometria PulsetTM 3cc 25U Heparina Balanceada	Class I
SA	ME0000010794SFDAA00009	Sensor Wrap ,5 strap w / hook tab	—
SA	ME0000010794SFDAA00040	Chin Strap	—
CA	65583	CIRCULAIRE AEROSOL DRUG DELIVERY SETS	Class II
CA	65584	VIXONE SMALL VOLUME NEBULIZER	Class II
CA	65586	HEATED BREATHING CIRCUITS	Class II

WESTMED, 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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