mesimedical.comMESI mTABLET SPIRO
Mesi D.O.O.
MESI D.O.O.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011861727 | 3011861727 | MESI D.O.O. | 1 | N | 2026-01-01 | Stegne 11a Ljubljana SI 1000 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 03830059851523 | MESI mTABLET TBI - 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. | +38616203487 | info@mesimedical.com |
| 03830059852216 | MESI mTABLET SPIRO - The MESI mTABLET SPIRO is an automated wireless spirometer device for diagnosing and screening patients with respiratory diseases. The system is intended to perform, view and store spirometry measurements of adult and paediatric patients. It is a wireless system which is comprised of a wireless medical grade tablet, spirometer module, disposable mouthpieces and charging station module. | +38616203487 | info@mesimedical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 208918 | 1229368075 | K251777 | MESI mTABLET SPIRO | BZG | 2026-03-02 |
| 208918 | 1645748033 | K223670 | MESI mTablet ECG Diagnostic System, MESI mTablet ECG | DPS | 2023-07-28 |
| 208918 | 1476677100 | K213730 | MESI mTABLET TBI diagnostic system, MESI mTABLET TBI | JOM | 2022-04-21 |
| 208918 | 1880356806 | K201046 | Automated ankle brachial pressure index measuring device, MESI mTABLET system | JOM | 2020-12-11 |
| 208918 | 1509671178 | K172655 | Automated ankle brachial pressure index measuring device | JOM | 2018-01-11 |
| 208918 | 1886574575 | K143152 | TM-ABI system | JOM | 2015-07-22 |
Product Codes Associated With Registrations#
PMN#
Automated Ankle Brachial Pressure Index Measuring Device, MESI MTABLET System
Mesi D.O.O.; Mesi, Development Of Medical Devices, Ltd.
Automated Ankle Brachial Pressure Index Measuring Device
Mesi D.O.O.; Mesi, Development Of Medical Devices, Ltd.
GUDID#
MESI mTABLET SPIRO - The MESI mTABLET SPIRO is an automated wireless spirometer device for diagnosing and screening patients with respiratory diseases. The system is intended to perform, view and store spirometry measurements of adult and paediatric patients. It is a wireless system which is comprised of a wireless medical grade tablet, spirometer module, disposable mouthpieces and charging station module.
2026-03-24
MESI mTABLET ECG Extension, BANANA AHA - 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.
2025-03-10
MESI mTABLET ECG - 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.
2023-11-21
MESI mTABLET TBI - 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.
2022-04-25
MESI ABPI MD - The MESI ABPI MD is an automated wireless ankle-brachial index measuring device for screening patients for Peripheral Arterial Disease (PAD/LEAD). The device is intended to perform, view and store ankle-brachial index (ABI) measurements of adult patients –patients in the PAD risk group.
2021-07-09
MESI mTABLET ABI - The MESI mTABLET ABI is an automated wireless ankle-brachial index measuring system for screening patients for Peripheral Arterial Disease (PAD/LEAD). The system is intended to perform, viewing and storing ankle-brachial index (ABI) measurement of adult patients –patients in the PAD risk group. It is a wireless system which is comprised of a wireless medical tablet system, four tubeless blood pressure cuff modules and a 4-port charging station module.
2021-07-09