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PARI RESPIRATORY EQUIPMENT, INC.

USA · Midlothian

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

6listed device types

Class I 3Class II 3Class III 0

plus 25 registration records and 10 510(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

5active device licences

Class II 5

27 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 States25 registration records, 10 510(k), 0 PMA, 4 excluded

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: PARI RESPIRATORY EQUIPMENT, INC.

FDA 510(k) clearances by year

12009

32010

12012

12016

12017

12020

12023

12025

FDA listed device types

Spirometer, Therapeutic (Incentive) 1Compressor, Air, Portable 1Nebulizer (Direct Patient Interface) 1Mask, Oxygen 1Tubing, Pressure And Accessories 1Applicator, Ent 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251572	eRapid with eTrack System	2025-12-19
US	K223840	eRapid Nebulizer System	2023-08-11
US	K191270	Proneb Max	2020-01-23
CA	6133	PARI PRONEB COMPRESSOR NEBULIZER SYSTEM	Class II
CA	7519	PRONEB TURBO COMPRESSOR NEBULIZER SYSTEM	Class II
CA	8617	DURA-NEB PORTABLE AIR COMPRESSORS	Class II

PARI RESPIRATORY EQUIPMENT, 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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