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iCare ST500

by Icare Finland Oy 3 variants

Ref Standard A2Model TA04

iCare ST500 (Standard A2) is a Class IIa device made by Icare Finland Oy, registered in EUDAMED on 7 Nov 2024 (Basic UDI-DI 643003385TA0453) with CE/MDR certificate FI22/00000011 valid until 6 Oct 2030 and cleared under FDA 510(k) K241447 on 27 Sep 2024, withdrawn (EUDAMED), active (FDA 510(k)) as of 24 Oct 2026.

Active Active in United States. Withdrawn in European Union.

CE MDR, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier SGS FIMKO OY

510(k) K241447↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberFI22/00000011 Date5 Jun 2026IssuedStatusWithdrawn No longer placed on the EU market expires 6 Oct 2030
United StatesFDA 510(k) 510(k) NumberK241447 Date27 Sep 2024IssuedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 643003385TA0453 registered 7 Nov 2024 Withdrawn· +1 more in the status table
  • FDA 510(k) K241447 decided 27 Sep 2024 Active

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

Timeline

4 dated events

  1. Cleared FDA 510(k) K241447
  2. Registered EUDAMED 643003385TA0453
  3. Certificate issued EUDAMED FI22/00000011
  4. Certificate expires EUDAMED FI22/00000011

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Withdrawn
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Model / reference
TA04, Standard A2
Primary DI / UDI-DI
06430033851876
Basic UDI-DI
643003385TA0453
Direct marketing DI
06430033851876
EMDN code
Z12120122 Tonometers
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000000501

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Properties

  • Measuring function
Other properties (13, all answered No)