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EpiMonitor by Empatica

by Empatica S.r.L. Italy EUDAMED510(k)GUDID

Ref EpiMonitor-IOSModel EpiMonitor by Empatica iOS Version510(k) K250515

Product code POSEMDN Z121002

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK250515 Date19 Jun 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number0853858006EpiAppX4 Basic UDI-DIDate6 Jun 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00853858006379 UDI-DIDate14 Aug 2024ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 22 Oct 2026

Trade Name
EpiMonitor by Empatica EUDAMED
EpiMonitor GUDID
Generic Name
Home seizure monitoring system
Model / Reference
EpiMonitor by Empatica iOS Version EUDAMED
EpiMonitor-IOS EUDAMED
EpiMonitor App iOS GUDID
Primary DI / UDI-DI
00853858006379
Basic UDI-DI
0853858006EpiAppX4
Direct Marketing DI
00853858006379
510(k) Number
FDA Product Code
POS, FLL, LEL
EMDN Code
Z121002 Nervous system monitoring systems
GMDN Term
Home seizure monitoring system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.1580, 880.2910, 882.5050
Special Device Type
Software
Market of Registration
Ireland
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
EpiMonitor by Empatica iOS Version
EpiMonitor-IOS
GUDID
EpiMonitor App iOS
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
IT-MF-000012905

Other devices from Empatica S.r.L.

See all devices from Empatica S.r.L. →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date
Other properties (21)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No

Sources (3)

  • EUDAMED 40c045f2-afc2-46ba-98a6-c584c1b9a5ca 85 fields · synced 22 Oct 2026
  • FDA UDI f50d8f20-a895-4515-b907-d7252ec60e2c 33 fields · synced 30 May 2026
  • FDA 510(k) K232915 1 fields · synced 18 May 2026