Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005324856

FEI Number

3005324856

Entity Name

Icare Finland Oy

City/State/Country

Vantaa Uusimaa, FI

Establishment Address

Ayritie 22, Vantaa Uusimaa 01510, FI

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Icare Finland Oy (Owner Number: 10022915)

Owner / Operator Contact Address

Icare Finland Oy, Ayritie 22, Vantaa, FI-18 01510, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211355

PMA Number

N/A

All Registered Proprietary Names

iCare IC200 iCare EXPORT iCare CLINIC iCare TP01s Probes iCare IC100 iCare HOME2 iCare EXPORT iCare CLINIC iCare PATIENT2 iCare TP022 Probes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2022-12-15
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2016-04-20
HKX	Tonometer, Ac-Powered	Ophthalmic	Class 2	886.1930	2016-04-20
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2022-02-02

Official Correspondent

Hannes Hyvonen

US Agent Details

STEVE WITTY Email: steve.witty@icare-world.com Phone: (844) 2134408

Related Public Records

Same Entity

Icare Finland Oy

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K870750	Keeler Instruments, Inc.	KEELER PULSAIR NON CONTACT TONOMETER	1987-03-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005324856. Last updated year: 2026. Please use registration number 3005324856 when referencing this establishment in official correspondence.