MESI mTABLET ECG

FDA UDI

Class II (US FDA UDI)

by MESI d.o.o.

Identity

Trade Name: MESI mTABLET ECG FDA UDI
Generic Name: Electrocardiograph, professional, multichannel FDA UDI
Device Name: The MESI mTABLET ECG is a portable 12-lead resting ECG system for screening cardiac abnormalities. The system is intended for acquiring, viewing, and storing signals from adult and pediatric patients. It is a wireless system that is comprised of the control unit (mTABLET) and diagnostic module (12-lead resting ECG) used solely in a professional clinical environment by trained healthcare personnel. FDA UDI
Model / Reference: MTABSYSECG FDA UDI
Description: The MESI mTABLET ECG is a portable 12-lead resting ECG system for screening cardiac abnormalities. The system is intended for acquiring, viewing, and storing signals from adult and pediatric patients. It is a wireless system that is comprised of the control unit (mTABLET) and diagnostic module (12-lead resting ECG) used solely in a professional clinical environment by trained healthcare personnel. FDA UDI

Identifiers

Catalog Number: 301-002007 FDA UDI
Primary DI / UDI-DI: 03830059851103 FDA UDI
510(k) Number: K223670 FDA UDI
FDA Product Code: DPS FDA UDI
GMDN Term: Electrocardiograph, professional, multichannel FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2340 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Electrocardiograph, professional, multichannel

MESI mTABLET ECG by MESI d.o.o. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K223670 also covers:

MESI mTABLET ECG Extension, BANANA AHA — MESI d.o.o.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: MESI d.o.o.

Sources (1)

FDA UDI fc831d7d-f045-486f-a79a-a934ea7f1e4a 35 fields · synced May 30, 2026