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Socrates

by Hedera Biomedics S.r.l. Italy EUDAMED

Ref SCR.001, SCR.002Model SOCRATES BASE, SOCRATES PRO

EMDN Z12140380

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-805714366SCR001AVNQ Basic UDI-DIDate30 Jan 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Socrates
Model / Reference
SOCRATES BASE, SCR.001, SOCRATES PRO, SCR.002
Primary DI / UDI-DI
D-805714366SCR001AVNQ, D-805714366SCR002AXNZ
Basic UDI-DI
B-805714366SCR001AVNQ, B-805714366SCR002AXNZ
EMDN Code
Z12140380 Evoked potential audiometry instruments - hardware accessories
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000039831

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (2)

  • EUDAMED 14a761aa-26bd-41b2-b25a-49beb09c30af 61 fields · synced 22 Oct 2026
  • EUDAMED D-805714366SCR002AXNZ|B-805714366SCR002AXNZ 61 fields · synced 19 May 2026