HomeItalyElesta S.P.A

Elesta S.P.A

Italy · Calenzano
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Australia, 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
3510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 1Class 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
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
Class I 2IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States0 registration records, 3 510(k), 0 PMA, 1 excluded
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: ELESTA S.P.A

Company information

Country
Italy
City
Calenzano

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

12022 · K213594
12023 · K230460
12026 · K260632

Registration details (sample)

MarketIdentifierNameClass / date
USK260632LASER THERMAL THERAPY KIT2026-03-17
USK230460Laser Thermal Therapy Kit2023-05-22
USK213594ECHOLASER X42022-05-03
BR80047309198KIT DE TERAPIA TÉRMICA A LASERClass II
BR80047300864ECHOLASER SMART INTERFACE ( EI KT0 0005 020)Class I

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