Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012933969

FEI Number

3012933969

Entity Name

EMPATICA S.r.l.

City/State/Country

Milano, IT

Establishment Address

Via Enrico Stendhal 36, Milano 20144, IT

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Empatica (Owner Number: 10058838)

Owner / Operator Contact Address

Via Stendhal 36, Milan, IT-25 20144, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252981

PMA Number

N/A

All Registered Proprietary Names

EpiMonitor EmbracePlus Care Portal Empatica Health Monitoring Platform Empatica Care Personal Kinetigraph (PKG) System Gen 2 Plus Empatica Health Monitoring Platform Empatica Care Care Portal EmbracePlus EmbraceMini EmbraceMini

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
POS	Physiological Signal Based Seizure Monitoring System	Neurology	Class 2	882.1580	2024-02-19
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-02-19
LEL	Device, Sleep Assessment	Neurology	Class 2	882.5050	2024-02-19
GZO	Device, Galvanic Skin Response Measurement	Neurology	Class 2	882.1540	2023-12-14
LEL	Device, Sleep Assessment	Neurology	Class 2	882.5050	2023-12-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-12-14
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2023-12-14
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2023-12-14
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-12-14
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2023-12-14
NXQ	Reminder, Medication	Physical Medicine	Class 1	890.5050	2025-11-26
GYD	Transducer, Tremor	Neurology	Class 2	882.1950	2025-11-26
ISD	Exerciser, Measuring	Physical Medicine	Class 2	890.5360	2025-11-26
GZO	Device, Galvanic Skin Response Measurement	Neurology	Class 2	882.1540	2025-11-26
LEL	Device, Sleep Assessment	Neurology	Class 2	882.5050	2025-11-26
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-11-26
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2025-11-26
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2025-11-26
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2025-11-26
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2025-11-26
ISD	Exerciser, Measuring	Physical Medicine	Class 2	890.5360	2025-09-12
LEL	Device, Sleep Assessment	Neurology	Class 2	882.5050	2026-01-07

Official Correspondent

Alberto Poli

US Agent Details

Matteo Lai Business: Empatica Inc Email: ml@empatica.com Phone: (415) 5483860

Related Public Records

Same Entity

Empatica

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

Similar Registrations

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3043349255	EpiWatch, Inc.	Baltimore, MD, US
3014886121	INTOPS CO.,LTD.	Suwon Gyeonggi, KR
3042639792	Unitron Medx LLC	Cary, NC, US
3017084392	LIVASSURED	Leiden Zuid-Holland, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012933969. Last updated year: 2026. Please use registration number 3012933969 when referencing this establishment in official correspondence.