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PKG Monitor by Empatica (iOS)

by Empatica S.r.L. Italy EUDAMED

Ref PKG-IOSModel Empatica Care - iOS Version EMDN Z12062592

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0853858006CARE42 Basic UDI-DIDate29 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Empatica Care
Model / Reference
Empatica Care - iOS Version, PKG-IOS
Primary DI / UDI-DI
00853858006690
Basic UDI-DI
0853858006CARE42
Direct Marketing DI
00853858006690
EMDN Code
Z12062592 Kinematic motion capture analysis systems - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Italy

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
Other properties (13)
  • Sterile: 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

Sources (1)

  • EUDAMED abd78fb2-b677-4fd1-a3b6-ffb201d41dea 61 fields · synced 22 Oct 2026