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Pulmodyne Inc.

USA · Indianapolis

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 10 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

20listed device types

Class I 10Class II 10Class III 0

plus 22 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

27registered devices

Class I 2Class II 25

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

14active device licences

Class II 14

34 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

10device registrations

CLASS B 10

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

12active ARTG entries

Class I 2IIa 9Class Im (measuring) 1

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

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 States22 registration records, 1 510(k), 0 PMA

Brazil27 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada14 confirmed, 0 excluded

Manufacturer names merged into this page: Pulmodyne Inc. · PULMODYNE · PULMODYNE, INC

FDA 510(k) clearances by year

12008 · K080256

FDA listed device types

showing 8 of 20

Filter, Bacterial, Breathing-Circuit 1Applicator (Laryngo-Tracheal), Topical Anesthesia 1Ventilator, Non-Continuous (Respirator) 1Monitor, Airway Pressure (Includes Gauge And/Or Alarm) 1Tube, Tracheostomy (W/Wo Connector) 1Spirometer, Diagnostic 1Attachment, Breathing, Positive End Expiratory Pressure 1Nebulizer (Direct Patient Interface) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K080256	PULMODYNE CHF FLOW GENERATOR SYSTEM	2008-05-09
BR	80504540002	Circuito descartável O2 Max para Sistema CPAP	Class II
BR	10342600051	CIRCUITO RESQ PARA SISTEMA CPAP	Class II
BR	81832589014	Máscara Full Face BiTrac Select	Class II
SA	ME0000007367SFDAA00014	TrachVox	—
CA	36627	PERTRACH	Class II
CA	60848	COBRA PLA	Class II
CA	73346	COBRAPLUS	Class II

Pulmodyne 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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