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Andersen Sterilizers, Inc.

USA · Haw River

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Australia, 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

4listed device types

Class I 0Class II 4Class III 0

plus 19 registration records and 19 510(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

0active device licences

5 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

2active registrations

Class 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 States19 registration records, 19 510(k), 0 PMA

Manufacturer names merged into this page: Andersen Sterilizers, Inc. · ANDERSEN STERILIZERS, INC.

FDA 510(k) clearances by year

62015

62017 · K170437

52020 · K200335

12021 · K202879

12022 · K213296

FDA listed device types

Wrap, Sterilization 1Sterilizer, Ethylene-Oxide Gas 1Indicator, Biological Sterilization Process 1Indicator, Physical/Chemical Sterilization Process 1

Market	Identifier	Name	Class / date
US	K213296	Anprolene SteriTest RRBI	2022-04-12
US	K202879	EOGas 4 Endo-SteriTest RRBI	2021-03-03
US	K200335	Sterisheet Sterilization Wrap	2020-11-12

Andersen Sterilizers, 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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