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Mesi D.O.O.: FDA-registered device maker in Ljubljana, Slovenia, 5 510(k) clearances

Name: Mesi D.O.O. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Mesi D.O.O. is registered with the FDA (registration 3011861727) in Ljubljana, Slovenia. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 2, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011861727
Address: Stegne 11a, Ljubljana, Slovenia, 1000
Owner or operator: MESI D.O.O. (10055183)
Roles: Manufacturer
First device listed: December 18, 2018
Registered through: 2026
Brand names listed: Automated Ankle-Brachial Pressure Index Measuring Device, Automated Wireless Ankle-Brachial Index Measuring System, MESI ABPI MD, MESI mTABLET ABI, MESI mTABLET ECG, MESI mTABLET SPIRO, MESI mTABLET TBI, Wireless 12-lead Resting ECG System and more

Devices it lists

Device	Product code	Class	Role	Source
Electrocardiograph	DPS	2	Manufacturer	accessdata.fda.gov
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic	JOM	2	Manufacturer	accessdata.fda.gov
Spirometer, Diagnostic	BZG	2	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
March 2, 2026	K251777	MESI mTABLET SPIRO	BZG	Substantially Equivalent	Mesi D.O.O.	accessdata.fda.gov
July 28, 2023	K223670	MESI mTablet ECG Diagnostic System, MESI mTablet ECG	DPS	Substantially Equivalent	Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.	accessdata.fda.gov
April 21, 2022	K213730	MESI mTABLET TBI diagnostic system, MESI mTABLET TBI	JOM	Substantially Equivalent	Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.	accessdata.fda.gov
December 11, 2020	K201046	Automated ankle brachial pressure index measuring device, MESI mTABLET system	JOM	Substantially Equivalent	Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.	accessdata.fda.gov
January 11, 2018	K172655	Automated ankle brachial pressure index measuring device	JOM	Substantially Equivalent	Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.	accessdata.fda.gov

Compare with other makers

Updated March 2, 2026. 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.