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iCare ST500

by Icare Finland Oy Finland EUDAMED

Ref Standard A1Model TA04

EMDN Z12120122

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberFI22/00000011 Date5 Jun 2026IssuedStatusActive expires 6 Oct 2030

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • FI22/00000011 Supplemented

    Quality management system EU MDR

    Notified body
    SGS FIMKO OY 0598
    Issued
    5 Jun 2026
    Expires
    6 Oct 2030
    Reason
    Add device or group

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
TA04, Standard A1
Primary DI / UDI-DI
06430033851616
Basic UDI-DI
643003385TA0453
Direct Marketing DI
06430033851616
EMDN Code
Z12120122 Tonometers
Device Class
Class IIa
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000000501

Other devices from Icare Finland Oy

See all devices from Icare Finland Oy →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 568ee026-52a6-4089-9654-de6c40a9756d 61 fields · synced 22 Oct 2026