Skip to content

Hda-100

by Sbm Sistemi S.R.L. Italy EUDAMED

Ref 15016

EMDN Z12120199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number80561498815016VF Basic UDI-DIDate21 Apr 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

Device Name
Strumenti Elettronici Optometrici
Model / Reference
15016
Primary DI / UDI-DI
08056149880005
Basic UDI-DI
80561498815016VF
EMDN Code
Z12120199 Ophtalmology assessments and diagnosis instruments – other
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
IT-MF-000026683

Other devices from Sbm Sistemi SRL

See all devices from Sbm Sistemi SRL →

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 abe65fa6-3213-43ae-bead-713bcd39371d 61 fields · synced 22 Oct 2026