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STERIS Corporation

Italy · St. Louis

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

349listed device types

Class I 230Class II 109Class III 10

plus 757 registration records and 227 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

12registered devices

Class I 5Class II 7

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

SASaudi ArabiaSFDA

73registered imported devices

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

CACanadaMDALL

9active device licences

Class II 9

43 including historic records

TWTaiwanTFDA

17valid device licences

Class I 7Class II 10

SGSingaporeHSA SMDR

19device registrations

CLASS B 10CLASS C 9

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

38active ARTG entries

Class I 27IIb 10Class Is (sterile) 1

HKHong KongMDACS

3valid listings

Class III 3

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

13active registrations

Class 1 2Class 2a 11

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 States757 registration records, 227 510(k), 0 PMA, 18 excluded

Brazil12 confirmed, 3 excluded

Saudi Arabia73 confirmed, 0 excluded

Canada9 confirmed, 2 excluded

Manufacturer names merged into this page: STERIS SPA · STERIS Corporation · STERIS CORPORATION · STERIS · STERIS AG · STERIS SAS

FDA 510(k) clearances by year

92007

72008

132009

82010

142011

62012

52013

62014

12015

62016

122017

262018

182019

82020

102021

122022

232023

142024

82025

42026

FDA listed device types

showing 8 of 349

Electrosurgical, Cutting & Coagulation & Accessories 1Forceps, Surgical, Gynecological 1Thoracolumbosacral Pedicle Screw System 1Sucker, Cardiotomy Return, Cardiopulmonary Bypass 1Light, Surgical, Accessories 1Clamp, Vascular 1Wrap, Sterilization 1Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261055	AMSCO 700 Steam Sterilizer	2026-06-24
US	DEN240075	Prolystica Pass Thru Disinfectant Wipes	2026-05-01
US	K251666	SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900	2026-04-08
BR	10259750032	Esterilizadores a vapor AMSCO - 300 Series, 400 Series e 600 Series	Class II
BR	10259750033	Sistema de processamento estéril SYSTEM 1 EXPRESS	Class II
BR	10259750035	LAVADORA/DESINFETADORA AMSCO	Class II
SA	ME0000000942SFDAA00019	Amsco Warming Cabinet	—
SA	ME0000000942SFDAA00002	Prolystica 2X Concentrates Enzymatic Presoak and Cleaner	—
CA	8206	STERIS SYSTEM 1	Class II
CA	84995	SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM	Class II
CA	86699	SYSTEM 1 PLUS STERILE PROCESSING SYSTEM	Class II