Tonoport VI

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

Blood pressure ambulatory recorder

Device Name

Ambulatory Blood Pressure Monitor

Model / Reference

S350 EUDAMED

2001589-202 GUDID

Primary DI / UDI-DI

04260671371021

Basic UDI-DI

426067137ABPMonitor3C

Direct Marketing DI

04260671371021

510(k) Number

K170966 ↗

FDA Product Code

DXN

EMDN Code

Z1203020501 Non–invasive oscillometric blood pressure gauges

GMDN Term

Blood pressure ambulatory recorder

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 870.1130

EU market of registration

Germany

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• LZBD Cuff Large mit D-Ring

  Class I

  CE/MDR

• LZBD Cuff Medium mit D-Ring

  Class I

  CE/MDR

• What types of patients can use the Tonoport VI blood pressure monitor, and what makes it suitable for them?

  The Tonoport VI is designed for measuring blood pressure in adults, pregnant women (including those with pre-eclampsia), and children, provided the correct-sized cuffs are used. Its oscillometric technology ensures accurate readings for these diverse patient groups, making it versatile for clinical and ambulatory settings where non-invasive monitoring is required.

• Is the Tonoport VI intended for single-use or reusable applications, and how does that affect its use?

  The Tonoport VI itself is a reusable device, but its compatibility with single-use or reusable cuffs depends on the specific cuff model selected. This flexibility allows clinicians to choose between disposable cuffs for hygiene in single-patient settings or reusable cuffs for cost efficiency in multi-patient environments, as long as proper cleaning and maintenance protocols are followed.

• Can the Tonoport VI be used in sterile environments, and what are its storage requirements?

  The Tonoport VI is explicitly designed for non-sterile settings, so it is not intended for use in sterile procedures or environments. Storage conditions should follow the manufacturer’s instructions, which likely include protection from extreme temperatures, moisture, and physical damage to ensure optimal performance and longevity.

• What regulatory pathways does the Tonoport VI follow, and which advisory committee was involved in its review?

  The Tonoport VI is authorized under FDA 510(k) clearance (K170966) and meets MDR (Medical Device Regulation) requirements. Its review was conducted by the FDA’s Cardiovascular (CV) Advisory Committee, with a decision classified as *Substantially Equivalent* under the DXN product code for blood pressure measurement devices.