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SBM SISTEMI SRL.

Italy · Rivalta Di Torino Torino

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 3 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 3Class II 2Class III 0

plus 5 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 3Class II 4

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

SASaudi ArabiaSFDA

12registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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.

Saudi Arabia: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.

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, 0 510(k), 0 PMA, 2 excluded

Brazil7 confirmed, 1 excluded

Saudi Arabia12 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: SBM SISTEMI SRL · SBM SISTEMI SRL. · SBM SISTEMI S.r.l. · SBM Sistemi S.R.L

Registration details (sample)

Market	Identifier	Name	Class / date
BR	81346500086	DSLC200 Sistema eletrônico optométrico	Class I
BR	81346500106	Sistema Optométrico Eletrônico - SBM Sistemi	Class I
BR	81346509093	Topógrafo de Córnea - SBM Sistemi	Class II

SBM SISTEMI SRL.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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