FDA.reportPublic FDA data

TIMPEL S.A.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30165097613016509761TIMPEL S.A.1N2026-01-01Rua Jose Leonardi 280 Bloco A Pato Branco Parana BR 85503

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2372372071540320K250464Enlight 2100 (TPL-E2103-0)QEB2025-09-10
2372371800334795K222897Enlight 2100QEB2023-03-07
2372372063710776K211135Enlight 2100QEB2022-01-06
2372371711863893DEN170072Enlight 1810QEB2018-12-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QEB42025-09-10

PMN#