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ZHERMACK S.P.A.

Italy · Badia Polesine (Ro)

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, South Korea, Australia, Israel, Russia — 9 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

3listed device types

Class I 2Class II 1Class III 0

plus 27 registration records and 19 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class I 3Class II 6

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

SASaudi ArabiaSFDA

13registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

TWTaiwanTFDA

12valid device licences

Class I 3Class II 9

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

9active ARTG entries

Class I 6IIa 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

24active registrations

Class 1 3Class 2a 21

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 States27 registration records, 19 510(k), 0 PMA, 1 excluded

Brazil9 confirmed, 0 excluded

Saudi Arabia13 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: ZHERMACK S.P.A. · ZHERMACK SPA. · ZHERMACK SPA

Registration details (sample)

Market	Identifier	Name	Class / date
US	K083739	HYDRORISE AND HYDROSYSTEM	2009-03-26
US	K081084	COLORISE RIGID	2008-05-14
US	K080130	OCCLUFAST CAD	2008-03-14
BR	80279919008	Thermo Clone VPS	Class II
BR	80745400040	Família de Resinas Bis-Acrilicas Autopolimerizáveis	Class II
BR	80745400037	FAMÍLIA DE SILICONES DE ADIÇÃO ZHERMACK	Class I
SA	ME0000005671SFDAA00037	HYDRORISE LIGHT BODY FAST SET	—
SA	ME0000005672SFDAA00017	Hydrorise	—
CA	74307	ELITE IMPLANT	Class II

ZHERMACK S.P.A.

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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