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SECHRIST INDUSTRIES, INC.

USA · Anaheim

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, 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

8listed device types

Class I 1Class II 7Class III 0

plus 13 registration records and 23 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

3 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

3active device licences

Class III 3

7 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

4active ARTG entries

Class I 1IIa 1IIb 2

HKHong KongMDACS

2valid listings

Class II 1Class III 1

ILIsraelAMAR

3registrations

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 States13 registration records, 23 510(k), 0 PMA, 1 excluded

Brazil2 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: SECHRIST INDUSTRIES, INC. · SECHRIST INDUSTRIES INC

FDA 510(k) clearances by year

11978

11980

21981

11982

11983

11984

11985

11986

21988

11989

11990

11992

11993

21995

21999

12003

12005

12010

12014

FDA listed device types

Mixer, Breathing Gases, Anesthesia Inhalation 1Stretcher, Wheeled 1Monitor, Carbon-Dioxide, Cutaneous 1Valve, Non-Rebreathing 1Ventilator, Continuous, Facility Use 1Gas Control Unit, Cardiopulmonary Bypass 1Chamber, Hyperbaric 1Medical Device Data System 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K140559	SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER	2014-05-30
US	K100268	SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER	2010-04-26
US	K052713	MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER	2005-10-28
BR	80259119023	Misturador de Ar/Oxigênio SECHRIST	Class II
BR	80259110171	Misturador de Ar/Oxigênio SECHRIST	Class II
CA	844	INFANT VENTILATOR	Class III
CA	872	AIRWAY PRESSURE MONITOR	Class III
CA	28173	MILLENNIUM INFANT / PEDIATRIC VENTILATOR	Class III