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ADVANCED STERILIZATION PRODUCTS, INC.

USA · Irvine

✓ 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

15listed device types

Class I 6Class II 9Class III 0

plus 44 registration records and 64 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 2Class II 1

5 including historic records

SASaudi ArabiaSFDA

117registered imported devices

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

CACanadaMDALL

0active device licences

7 including historic records

TWTaiwanTFDA

11valid device licences

Class I 3Class II 8

SGSingaporeHSA SMDR

3device registrations

CLASS C 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

12active ARTG entries

Class I 10IIb 2

HKHong KongMDACS

4valid listings

Class III 4

ILIsraelAMAR

11registrations

RURussiaRoszdravnadzor

5active registrations

Class 1 3Class 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 States44 registration records, 64 510(k), 0 PMA, 39 excluded

Brazil3 confirmed, 3 excluded

Saudi Arabia117 confirmed, 0 excluded

Canada0 confirmed, 3 excluded

Manufacturer names merged into this page: ADVANCED STERILIZATION PRODUCTS · ADVANCED STERILIZATION PRODUCTS, INC. · ADVANCED STERILIZATION PRODUCTS, INC., · ADVANCED STERILIZATION PRODUCTS DISTRIBUICAO E COMERCIO DE PRODUTOS PARA SAUDE LTDA · Advanced Sterilization Products Division of Ethicon,Inc. A Johnson & Johnson Company · Advanced Sterilization Products Division of Ethicon, Inc. a Johnson & Johnson Company

FDA 510(k) clearances by year

42003

12004

52005

12006

32007

12008

72011

82012

32014

22015

42016

32017

12018

12019

12020

12021

12022

22024

12025

12026

FDA listed device types

showing 8 of 15

Indicator, Physical/Chemical Sterilization Process 1Wrap, Sterilization 1Indicator, Biological Sterilization Process 1Accessories, Cleaning, For Endoscope 1Sterilant, Medical Devices 1Sterilizer, Ethylene-Oxide Gas 1Ultraviolet Radiation Disinfection Chamber Device 1Sterilizer, Chemical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252843	STERRAD 100NX Sterilization System with ALLClear Technology (10104)	2026-04-15
US	K250802	STERRAD® 100NX Sterilizer with ALLClear Technology (10104)	2025-04-14
US	K234082	STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104); APTIMAX Instrument Tray for ULTRA GI Cycle (011077)	2024-07-05
BR	82060170002	CASSETE DE PERÓXIDO DE HIDROGÊNIO STERRAD	Class I
BR	82060170001	CASSETE DE PERÓXIDO DE HIDROGÊNIO STERRAD	Class I
BR	82060179001	Sistema de Esterilização STERRAD	Class II
SA	ME0000003217SFDAA00033	CIDEX	—
SA	ME0000003217SFDAA00031	APTIMAX	—

ADVANCED STERILIZATION PRODUCTS, 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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