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W&H STERILIZATION S.R.L.

Italy · Brusaporto

✓ 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

2listed device types

Class I 0Class II 2Class III 0

plus 5 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

3active device licences

Class II 3

9 including historic records

TWTaiwanTFDA

6valid device licences

Class II 6

SGSingaporeHSA SMDR

8device registrations

CLASS C 8

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

8active ARTG entries

Class I 4IIb 4

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 3

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 States5 registration records, 4 510(k), 0 PMA, 41 excluded

Brazil1 confirmed, 4 excluded

Saudi Arabia0 confirmed, 7 excluded

Canada3 confirmed, 3 excluded

Manufacturer names merged into this page: W&H STERILIZATION S.R.L.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233504	Lexa MINI (RIS-303, RIS-305)	2024-02-08
US	K223858	Lexa MINI (RIS-303, RIS-305)	2023-05-05
US	K213758	Lexa PLUS RIS-311	2022-08-19
BR	80047309229	Lisa MINI	Class II
CA	70262	BMAX STEAM STERILIZERS	Class II
CA	74517	LISA WATER STEAM STERILIZERS	Class II
CA	101028	LISA VA131 STERILIZERS	Class II

W&H STERILIZATION S.R.L.

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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