MESI mTABLET SPIRO

GUDID 03830059852216

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.

MESI d.o.o.

Diagnostic spirometer, professional

• Primary Device ID: 03830059852216
• NIH Device Record Key: 1b6fd806-59ba-4699-aa78-2c6000add35e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MESI mTABLET SPIRO
• Version Model Number: MTABSYSSPIRO
• Company DUNS: 500719478
• Company Name: MESI d.o.o.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +38616203487
• Email: info@mesimedical.com
• Phone: +38616203487
• Email: info@mesimedical.com
• Phone: +38616203487
• Email: info@mesimedical.com
• Phone: +38616203487
• Email: info@mesimedical.com
• Phone: +38616203487
• Email: info@mesimedical.com
• Phone: +38616203487
• Email: info@mesimedical.com
• Phone: +38616203487
• Email: info@mesimedical.com
• Phone: +38616203487
• Email: info@mesimedical.com
• Phone: +38616203487
• Email: info@mesimedical.com
• Phone: +38616203487
• Email: info@mesimedical.com
• Phone: +38616203487
• Email: info@mesimedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03830059852216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251777

FDA Product Code

• BZG: Spirometer, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-04-01
• Device Publish Date: 2026-03-24

Devices Manufactured by MESI d.o.o.

• 03830059852216 - MESI mTABLET SPIRO: 2026-04-01The 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.
• 03830059852216 - MESI mTABLET SPIRO: 2026-04-01 The MESI mTABLET SPIRO is an automated wireless spirometer device for diagnosing and screening patients with respiratory disease
• 03830059853220 - MESI mTABLET ECG Extension, BANANA AHA: 2025-03-18 The MESI mTABLET ECG is a portable 12-lead resting ECG system for screening cardiac abnormalities. The system is intended for ac
• 03830059851103 - MESI mTABLET ECG: 2023-11-29 The MESI mTABLET ECG is a portable 12-lead resting ECG system for screening cardiac abnormalities. The system is intended for ac
• 03830059851523 - MESI mTABLET TBI: 2022-05-03 Wireless Toe Brachial Index System
• 03830059850366 - MESI ABPI MD: 2021-07-19 The MESI ABPI MD is an automated wireless ankle-brachial index measuring device for screening patients for Peripheral Arterial
• 03830059851141 - MESI mTABLET ABI: 2021-07-19 The MESI mTABLET ABI is an automated wireless ankle-brachial index measuring system for screening patients for Peripheral Arteri