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VORTRAN MEDICAL TECHNOLOGY 1, INC.

USA · Sacramento

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Taiwan, Russia — 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

5listed device types

Class I 0Class II 5Class III 0

plus 10 registration records and 28 510(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 4Class III 1

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 2b 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 States10 registration records, 28 510(k), 0 PMA

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: VORTRAN MEDICAL TECHNOLOGY 1, INC.

FDA 510(k) clearances by year

21984

11987

11990

11991

31992

31993

31994

11996

31998

12000

12001

12004

12008

12011

12016

12017

12018

12019

12021

FDA listed device types

Monitor, Airway Pressure (Includes Gauge And/Or Alarm) 1Compressor, Air, Portable 1Cuff, Tracheal Tube, Inflatable 1Ventilator, Emergency, Powered (Resuscitator) 1Device, Positive Pressure Breathing, Intermittent 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K202219	VORTRAN GO2VENT with PEEP Valve	2021-02-11
US	K182292	VORTRAN APM-Plus	2019-09-18
US	K173914	VORTRAN Cuff Inflator (VCI)	2018-05-25
CA	61854	VORTRAN-IPPB	Class II
CA	62338	VORTRAN AUTOMATIC RESUSCITATOR	Class III
CA	76153	E-VENT CASE	Class II

VORTRAN MEDICAL TECHNOLOGY 1, 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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