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MESI mTABLET TBI

FDA UDI

Class II (US FDA UDI)

by MESI d.o.o.

Identity

Trade Name
MESI mTABLET TBI FDA UDI
Generic Name
Automatic-inflation electronic sphygmomanometer, portable, finger FDA UDI
Device Name
The MESI mTABLET TBI is an automated wireless Toe-Brachial Index measuring system for screening patients for Peripheral Arterial Disease (PAD/LEAD). The system is intended to perform, view, and store toe-brachial index (TBI) measurements of adult patients - patients in the PAD risk group - especially diabetic, renal, and elder patients who may suffer from calcified vessels. It is a wireless system that is comprised of a wireless medical tablet system, a toe blood pressure module, two tubeless blood pressure cuff modules, and a 4-port charging station module. MESI mTABLET TBI is intended to be used in a professional clinical environment by trained healthcare personnel who understand the principle of toe-brachial index (TBI) measurement and are able to place arm cuffs, digit cuffs and photoplethysmographic (PPG) probes on the patient body, as well as able to verify that these accessories are working as intended and to start the measurement process. FDA UDI
Model / Reference
MTABSYSTBI FDA UDI
Description
The MESI mTABLET TBI is an automated wireless Toe-Brachial Index measuring system for screening patients for Peripheral Arterial Disease (PAD/LEAD). The system is intended to perform, view, and store toe-brachial index (TBI) measurements of adult patients - patients in the PAD risk group - especially diabetic, renal, and elder patients who may suffer from calcified vessels. It is a wireless system that is comprised of a wireless medical tablet system, a toe blood pressure module, two tubeless blood pressure cuff modules, and a 4-port charging station module. MESI mTABLET TBI is intended to be used in a professional clinical environment by trained healthcare personnel who understand the principle of toe-brachial index (TBI) measurement and are able to place arm cuffs, digit cuffs and photoplethysmographic (PPG) probes on the patient body, as well as able to verify that these accessories are working as intended and to start the measurement process. FDA UDI

Identifiers

Catalog Number
301-003767 FDA UDI
Primary DI / UDI-DI
03830059851523 FDA UDI
510(k) Number
K213730 FDA UDI
FDA Product Code
JOM FDA UDI
GMDN Term
Automatic-inflation electronic sphygmomanometer, portable, finger FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2780 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Automatic-inflation electronic sphygmomanometer, portable, finger

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

Similar devices

Also classified as Automatic-inflation electronic sphygmomanometer, portable, finger.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
MESI d.o.o.

Sources (1)

  • FDA UDI d847825c-17de-4870-8d64-7c157128c6c9 36 fields · synced May 30, 2026