FDA.reportPublic FDA data

EMPATICA S.r.l.

Matched from indexed company URL: Empatica S.r.l.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30129339693012933969EMPATICA S.r.l.1N2026-01-01Via Enrico Stendhal 36 Milano Milano IT 20144

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2237771238392699K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care PortalGYD2026-08-14
2237771010778722K252981EmbraceMiniLEL2025-12-22
2237771393460688K250515EpiMonitorPOS2025-06-19
2237771118702866K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalMWI2025-06-06
2237771840397680K232915EpiMonitorPOS2024-02-15
2237771337908707K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalMWI2023-10-30
2237771336288944K221282Empatica Health Monitoring PlatformDQA2022-11-20
2237771515494848K211887Personal Kinetigraph (PKG) System Gen 2 PlusGYD2022-03-11
2237771927268719K181861EmbracePOS2018-12-20
2237771508123247K172935EmbracePOS2018-01-26
2237771040715580

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
POS42025-06-19
GYD22026-08-14
MWI22025-06-06
LEL12025-12-22
DQA12022-11-20

PMN#

GUDID#