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PASSY-MUIR, INC.

USA · Irvine

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Australia, Israel — 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 2Class II 3Class III 0

plus 10 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

0active device licences

1 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

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 States10 registration records, 5 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: PASSY-MUIR, INC. · PASSY-MUIR INC. · PASSY-MUIR INC

FDA 510(k) clearances by year

11995 · K944451

11996 · K962714

11997 · K970365

11999 · K990905

12023 · K230483

FDA listed device types

Tube, Tracheostomy (W/Wo Connector) 1Filter, Bacterial, Breathing-Circuit 1Tube Tracheostomy And Tube Cuff 1Connector, Airway (Extension) 1Condenser, Heat And Moisture (Artificial Nose) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K230483	Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)	2023-09-16
US	K990905	PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT	1999-06-11
US	K970365	PASSY-MUIR O2 ADAPTER; PMA2000	1997-02-12
BR	80789360002	VALVULAS ACRÍLICAS PARA TRAQUEOSTOMIA PASSY-MUIR	Class II
BR	80789360001	VÁLVULAS PARA TRAQUEOSTOMIA PASSY-MUIR	Class II

PASSY-MUIR, 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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