FDA.reportPublic FDA data

Voluntis

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30135303413013530341Voluntis1N2026-01-0112-14 Rue Louis Bleriot Rueil-Malmaison Hauts-de-Seine FR 92500

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2026681481810185K250022HeroTracker SenseCAF2025-06-30
2026681410069674K172177Insulia Diabetes Management CompanionNDC2017-11-07
2026681923164405K170669Insulia Diabetes Management CompanionNDC2017-06-19
2026681143361507K161433Insulia Diabetes Management CompanionNDC2016-11-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NDC32017-11-07
CAF12025-06-30

PMN#

GUDID#