Skip to content

iCare HOME2

by Icare Finland Oy 9 variants

Ref Standard A2Model TA023

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS FIMKO OY

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberFI22/00000011 Date5 Jun 2026IssuedStatusWithdrawn No longer placed on the EU market expires 6 Oct 2030

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • FI22/00000011 Active Supplemented

    Quality management system EU MDR

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Withdrawn

Specification

EUDAMED

Model / Reference
TA023, Standard A2
Primary DI / UDI-DI
06430033851388
Basic UDI-DI
643003385TA023XC
Direct Marketing DI
06430033851388
EMDN Code
Z12120122 Tonometers
Device Class
Class IIa
EU 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

  • 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