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ST500 Adapter

by Icare Finland Oy

Ref 556AModel TD01

ST500 Adapter (556A) is a device classified as Class I in the EU and Class II in the US made by Icare Finland Oy, registered in EUDAMED on 7 Nov 2024 (Basic UDI-DI 643003385TD015C), cleared under FDA 510(k) K241447 on 27 Sep 2024 and listed in FDA GUDID since 7 Nov 2024 (UDI-DI 06430033851791), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241447

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number643003385TD015C Basic UDI-DI 06430033851791UDI-DIDate7 Nov 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number06430033851791 UDI-DI Date7 Nov 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK241447 Date27 Sep 2024IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 643003385TD015C registered 7 Nov 2024 Active
  • FDA 510(k) K241447 decided 27 Sep 2024 Active
  • FDA GUDID UDI-DI 06430033851791 listed 7 Nov 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K241447
  2. Registered EUDAMED 643003385TD015C
  3. Listed FDA GUDID 06430033851791

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Static ophthalmic equipment stand, manually-adjusted
Model / reference
TD01, 556A
Primary DI / UDI-DI
06430033851791
Basic UDI-DI
643003385TD015C
510(k) Number
FDA product code
HKX, HKY
EMDN code
Z12129001 Ophthalmological instrument stands
GMDN term
Static ophthalmic equipment stand, manually-adjusted
Device class
Class I EUDAMED
Class II GUDID
Regulation number
886.1930
EU registration type
Standard device
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
FI-MF-000000501

Similar devices in this category

Other devices filed under OPHTHALMOLOGICAL INSTRUMENT STANDS.

Other devices from Icare Finland Oy

See all devices from Icare Finland Oy →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)