Vital Signs Monitor iM3s, iM3As, iM3Bs, iHM3s

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

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

• • Ongoing Z-1144-2026 FDA Class II ·initiated 24 Oct 2025

  As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Full name

Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s

Trade Name

Vital Signs Monitor

Generic Name

General-purpose multi-parameter bedside monitor

Model / Reference

iM3Bs, iM3As, ES3

Primary DI / UDI-DI

06944413813458, 06944413813441, 06944413849174

Basic UDI-DI

69444138iM3SS2J, 69444138ES3STG

510(k) Number

K233038 ↗

K202892 ↗

FDA Product Code

MWI, DQA, FLL, DXN

EMDN Code

Z1203020202 Transportable/portable multi–parameter patient monitors

GMDN Term

General-purpose multi-parameter bedside monitor

Device Class

Class IIb EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 870.2300 510(k)GUDID

870.2700 GUDID

880.2910 GUDID

870.1130 GUDID

EU market of registration

Germany

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

MRI Safety

MR Unsafe

• SpO2 sensor

  Class IIb

  CE/MDR

• NIBP Cuff

  Class I

  CE/MDR

• Temperature Probe

  Class IIb

  CE/MDR

• Biofeedback and Stimulation System

  Class IIa

  CE/MDR

• Ultrasonic Pocket Doppler

  Class IIa

  CE/MDR

• ECG Cable

  Class I

  CE/MDR

See all devices from Edan Instruments, Inc. →

• Are these monitors meant for single-use or can they be reused in a clinical setting?

  These monitors (iM3s, iM3As, iM3Bs, and iHM3s) are explicitly labeled as reusable medical devices, designed for repeated use in hospital environments like intensive care units and general wards. Since they are not described as single-use, they should be cleaned and maintained according to standard hospital protocols for reusable medical equipment.

• What types of vital signs can the iM3s/iM3As/iM3Bs/iHM3s models measure, and how are they displayed?

  The device continuously measures and displays heart rate, blood pressure, oxygen saturation (SpO₂), and respiratory rate in real-time. These metrics are intended to support patient assessment and monitoring by providing immediate physiological data for clinical decision-making in settings like ICUs and wards.

• What is the regulatory pathway for these monitors, and which advisory committee was involved?

  The monitors (iM3s, iM3As, iM3Bs, and iHM3s) follow the FDA 510(k) pathway and are also authorized under MDR (Medical Device Regulation). The Cardiovascular (CV) Advisory Committee reviewed the submission, and the device was determined to be substantially equivalent to a predicate under the Traditional 510(k) clearance type.

• Are there different models, and if so, how do they differ in terms of intended use?

  Yes, the device family includes iM3s, iM3As, iM3Bs, and iHM3s, all classified under product code MWI (Monitoring, Vital Signs). While the exact functional differences between the models aren’t detailed here, they are all designed for continuous monitoring of vital signs in clinical settings, including intensive care and general wards. The variations may relate to features or configurations rather than core indications.

• How should these monitors be stored, and are there any special considerations for their environment?

  The data does not specify storage conditions, but as reusable hospital-grade devices, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Since they are intended for intensive care and ward use, proper maintenance and calibration protocols should be followed to ensure accuracy and reliability in clinical settings.