Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009496855

FEI Number

3009496855

Entity Name

VALUKUMPU OY

City/State/Country

Joensuu Pohjois-Karjala, FI

Establishment Address

Raivaajantie 1, Joensuu Pohjois-Karjala 80100, FI

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Valukumpu Oy (Owner Number: 10038905)

Owner / Operator Contact Address

Raivaajantie 1, Joensuu, FI-13 80100, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

iCare ST500 (TA04)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2024-12-02
HKX	Tonometer, Ac-Powered	Ophthalmic	Class 2	886.1930	2024-12-02

Official Correspondent

Elli Majoinen

US Agent Details

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

Related Public Records

Same Entity

Valukumpu 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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1000391004	KEELER LTD.	WINDSOR, BERKSHIRE Windsor and Maidenhead, GB
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009496855. Last updated year: 2026. Please use registration number 3009496855 when referencing this establishment in official correspondence.