FDA.reportPublic FDA data

Icare Finland Oy

Matched from indexed company URL: ICARE FINLAND OY

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30053248563005324856Icare Finland Oy1N2026-01-01Ayritie 22 Vantaa Uusimaa FI 01510

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
709891017686192K241447iCare ST500 (TA04)HKY2024-09-27
709891624985229K220852iCare IC200HKY2022-10-06
709891178235149K211355iCare HOME2HKY2022-01-25
709891496746114K200966Icare HOME TonometerHKY2020-05-07
709891684482359K190316Icare ic200HKY2020-01-14
709891698717057K163343Icare HOME tonometerHKY2017-03-21
709891517644187K153694Icare ic100HKY2016-04-19
709891664817212K063873ICARE TONOMETER TA01IHKY2007-05-23

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HKY82024-09-27

PMN#

GUDID#

Icare ic200 - The Icare ic200 (TA031) tonometer is a hand-held, battery operated device, which measures intraocular pressure (IOP) without the need for topical anesthesia. The Icare ic200 tonometer measures the IOP by utilizing the rebound method. The Icare ic200 tonometer is intended to be used for the measurement of intraocular pressure of the human eye. Icare ic200 allows IOP measurement of patients in all positions between sitting and supine positions. IOP measurement result can be transferred to printer or to a PC via Bluetooth connection.

ICARE FINLAND OY

2020-01-17