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Full

by CAPSULA S.r.l. Italy EUDAMED

Ref FLModel FULL

EMDN Z12040199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805894684KIT2NX Basic UDI-DIDate6 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
FULL, FL
Primary DI / UDI-DI
08058946840022
Basic UDI-DI
805894684KIT2NX
EMDN Code
Z12040199 General medicine diagnosis and monitoring instruments - other
Device Class
Class IIa
Medical Purpose
Chiosco per l’autovalutazione di parametri fisiologici e di wellness

Manufacturer details

EUDAMED SRN
IT-PR-000044677

Other devices from CAPSULA S.r.l.

Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED b59513b6-6eb8-4ccc-979f-f0e46e5d8472 61 fields · synced 22 Oct 2026