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Home›Italy›SPES MEDICA S.R.L.

SPES MEDICA S.R.L.

Italy · Battipaglia
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Israel — 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
9listed device types
Class I 1Class II 8Class III 0
plus 16 registration records and 9 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
21registered devices
Class I 7Class II 14
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
4registered 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
3registrations
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 States16 registration records, 9 510(k), 0 PMA
Brazil21 confirmed, 0 excluded
Saudi Arabia4 confirmed, 0 excluded
Manufacturer names merged into this page: SPES MEDICA S.P.A · SPES MEDICA S.R.L · SPES MEDICA S.R.L. · Spes Medica S.R.L
Same-named companies — This database also contains companies with near-identical names: SPES MEDICA S.P.A. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Italy
City
Battipaglia

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 510(k) clearances by year

12009
12010
12012
12014
22019
12020
12021
12022

FDA listed device types

showing 8 of 9
Electrode, Needle 1Media, Electroconductive 1Cable, Electrode 1Electrode, Cutaneous 1Electrode, Cortical 1Stimulator, Nerve 1Electrode, Needle, Diagnostic Electromyograph 1Cystometric Gas (Carbon-Dioxide) On Hydraulic Device 1

Registration details (sample)

MarketIdentifierNameClass / date
USK211954Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid2022-11-10
USK212326AC Cream - Conductive paste2021-12-01
USK192606SAC2 - Electrode Cream2020-01-17
BR81210770012KIT PARA MONITORIZAÇÃO NEUROFISIOLÓGICA DE TIREÓIDEClass II
BR81210770019AC CREAM Pasta Adesiva e CondutoraClass I
BR81210770017SENSORES PARA POLISSONOGRAFIAClass II
SAME0000001352SFDAA00001Abrasive Skin Gel—
SAME0000001351SFDAA00001AC Cream—

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