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EMPATICA S.r.l.

Italy · Milan

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Israel — 3 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

11listed device types

Class I 1Class II 10Class III 0

plus 10 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

2 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States10 registration records, 9 510(k), 0 PMA

Manufacturer names merged into this page: EMPATICA S.r.l. · EMPATICA S.R.L.

FDA 510(k) clearances by year

22018 · K181861

12022 · K221282

12023 · K230457

12024 · K232915

32025 · K252981

12026 · K260374

FDA listed device types

showing 8 of 11

Physiological Signal Based Seizure Monitoring System 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Monitor, Breathing Frequency 1Exerciser, Measuring 1Continuous Measurement Thermometer 1Device, Galvanic Skin Response Measurement 1Oximeter 1Transducer, Tremor 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260374	Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal	2026-08-14
US	K252981	EmbraceMini	2025-12-22
US	K250515	EpiMonitor	2025-06-19

EMPATICA S.r.l.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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