Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010287677

FEI Number

3010287677

Entity Name

MARIACHI OY

City/State/Country

Littoinen Varsinais-Suomi, FI

Establishment Address

Kaarinantie 700, Littoinen Varsinais-Suomi 20660, FI

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Mariachi Oy (Owner Number: 10043088)

Owner / Operator Contact Address

Kaarinantie 700, Littoinen, FI-19 20660, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

iCare HOME2 LymphaTouch; LymphaTouch Pro iCare; iCare tonometer Icare IC200 Tonometer Icare Ic100

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2022-02-04
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2025-11-30
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2013-01-24
HKX	Tonometer, Ac-Powered	Ophthalmic	Class 2	886.1930	2013-01-24
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2025-04-08
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2016-12-23
HKX	Tonometer, Ac-Powered	Ophthalmic	Class 2	886.1930	2016-12-23

Official Correspondent

Pasi Hatakka

US Agent Details

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

Related Public Records

Same Entity

Mariachi 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 3010287677. Last updated year: 2026. Please use registration number 3010287677 when referencing this establishment in official correspondence.