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Home›Italy›SBM SISTEMI SRL.

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.

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

Company information

Country
Italy
City
Rivalta Di Torino Torino

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA listed device types

Camera, Ophthalmic, General-Use 1Pad, Heating, Powered 1Topographer, Corneal, Ac-Powered 1Pupillometer, Ac-Powered 1Light, Examination, Medical, Battery Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
BR81346500086DSLC200 – Sistema eletrônico optométricoClass I
BR81346500106Sistema Optométrico Eletrônico - SBM SistemiClass I
BR81346509093Topógrafo de Córnea - SBM SistemiClass II
SAME0000010215SFDAA00001LACRYDIAG—
SAME0000010215SFDAA00002IDRA—

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