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Innokas Medical Estonia Ou: FDA-registered device maker in Tallinn Harjumaa, Estonia, 1 510(k) clearance

Name: Innokas Medical Estonia Ou FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Innokas Medical Estonia Ou is registered with the FDA (registration 3010399798) in Tallinn Harjumaa, Estonia. It lists 11 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 30, 2014. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010399798
Address: Paneeli 2, Tallinn Harjumaa, Estonia, 13816
Owner or operator: Innokas Yhtyma Oy (10026175)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer
First device listed: November 11, 2014
Registered through: 2026
Brand names listed: Cary, Coala Heart Monitor, Icare HOME Tonometer, Icare ic200 tonometer, Keikku, Nox A1s Recorder, Nox T3s Recorder, OFC100L, Oivi Fundus Camera and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Gas, Oxygen, Gaseous-Phase	CCL	2	Contract manufacturer	accessdata.fda.gov
Apparatus, Suction, Ward Use, Portable, Ac-Powered	JCX	2	Contract manufacturer	accessdata.fda.gov
Automatic Event Detection Software For Polysomnograph With Electroencephalograph	OLZ	2	Contract manufacturer	accessdata.fda.gov
Camera, Ophthalmic, General-Use	PJZ	2	Contract manufacturer	accessdata.fda.gov
Colorimeter, Photometer, Spectrophotometer For Clinical Use	JJQ	1	Contract manufacturer	accessdata.fda.gov
Device, Muscle Monitoring	KZM	2	Contract manufacturer	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
Stethoscope, Electronic	DQD	2	Contract manufacturer	accessdata.fda.gov
Tonometer, Manual	HKY	2	Contract manufacturer	accessdata.fda.gov
Transmitters And Receivers, Electrocardiograph, Telephone	DXH	2	Contract manufacturer	accessdata.fda.gov
Ventilatory Effort Recorder	MNR	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 30, 2014	K133810	VC150 VITAL SIGNS MONITOR	MWI	Substantially Equivalent	Innokas Yhtyma	accessdata.fda.gov

Compare with other makers

Updated October 30, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.