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EpiMonitor sky blue

by Empatica S.r.L. Italy EUDAMED

Ref EPI-1G-FB-SBModel EpiMonitor powered by EmbracePlus EMDN Z121002

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0853858006EpiDevWW Basic UDI-DIDate6 Jun 2025RegisteredStatusActive

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  • Withdrawn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
EpiMonitor powered by EmbracePlus
Model / Reference
EpiMonitor powered by EmbracePlus, EPI-1G-FB-SB
Primary DI / UDI-DI
00853858006560
Basic UDI-DI
0853858006EpiDevWW
EMDN Code
Z121002 Nervous system monitoring systems
Device Class
Class IIa
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 bb335b41-0a56-45c6-959e-027ff84736c7 61 fields · synced 22 Oct 2026