HomeMexicoSTERIS MEXICO, S. de R.L. de C.V.

STERIS MEXICO, S. de R.L. de C.V.

Mexico · Guadalupe
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, South Korea, Australia, Israel — 6 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 42 registration records and 0 510(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
6active device licences
Class II 6
13 including historic records
TWTaiwanTFDA
3valid device licences
Class II 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
1active ARTG entries
IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States42 registration records, 0 510(k), 0 PMA, 24 excluded
Brazil0 confirmed, 5 excluded
Saudi Arabia0 confirmed, 3 excluded
Canada6 confirmed, 3 excluded
Manufacturer names merged into this page: STERIS MEXICO, S. de R.L. de C.V. · STERIS MEXICO, S. DE R.L. DE C.V.

Company information

Country
Mexico
City
Guadalupe

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA listed device types

Sterilizer Automated Loading System 1Sterilizer, Ethylene-Oxide Gas 1Sterilizer, Steam 1Sterilizer, Chemical 1Washer, Cleaner, Automated, Endoscope 1

Registration details (sample)

MarketIdentifierNameClass / date
CA8203STERIS AMSCO CENTURY SERIES SMALL STERILIZERSClass II
CA10180STERIS AMSCO EAGLE 3017 %100 EO STERILZER/AERATORClass II
CA10181STERIS AMSCO EAGLE 3000 SERIES PREVACUUM STERILIZERSClass II

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