i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)

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.

Device Name

i3 ONE

Model / Reference

203100

Primary DI / UDI-DI

04260632190043

Basic UDI-DI

4260632192031008Y

Direct Marketing DI

04260632190043

510(k) Number

K222727 ↗

FDA Product Code

NHV

EMDN Code

V9099 Various devices not included in other classes - other

Models / Variants

i3 ONE (203100-S)

i3 TWO connect (203200-S)

i3 TWO direct (203300-S)

Device Class

Class I EUDAMED

Class II 510(k)

Regulation

21 CFR Part 876.5665

EU market of registration

Germany

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• i3 ONE 203100-S

  Class II

  GUDID on market

• i3 TWO connect 203200-S

  Class II

  GUDID on market

• i3 TWO direct 203300-S

  Class II

  GUDID on market

• i3 TWO direct

  Class I

  CE/MDR

• i3 TWO connect

  Class I

  CE/MDR

• What clinical settings or procedures would benefit most from using the i3 ONE, i3 TWO connect, or i3 TWO direct water purification systems?

  These systems are designed for environments where purified water is essential, such as healthcare facilities, hospitals, or clinics. They are particularly useful for providing water suitable for drinking, hand washing, and minor wound cleansing, which helps maintain infection control standards. While not intended for direct patient treatment, they support procedural hygiene in gastroenterology and urology settings, where clean water is critical for equipment cleaning and patient care.

• Are the i3 ONE, i3 TWO connect, and i3 TWO direct systems single-use or reusable, and how does this affect their maintenance?

  These devices are explicitly labeled as reusable medical devices, meaning they are built for long-term use in clinical settings. Since they are not single-use, proper maintenance—including regular cleaning, filter replacements, and adherence to manufacturer guidelines—is required to ensure consistent performance and compliance with EPA drinking water standards. Reusability also reduces waste, making them cost-effective for facilities with ongoing water purification needs.

• What regulatory pathways have these devices undergone, and how does that impact their use in medical facilities?

  The i3 systems have undergone FDA 510(k) clearance and comply with EU MDR (Medical Device Regulation) requirements. This means they meet U.S. and European safety and performance standards for general medical use water purification. Facilities can rely on their regulatory approvals to ensure these devices are suitable for installation in healthcare settings where purified water is required, though local compliance with facility protocols (e.g., water quality testing) may still apply.

• How are these systems supplied, and what should buyers consider when ordering or installing them?

  The i3 ONE (203100-S), i3 TWO connect (203200-S), and i3 TWO direct (203300-S) are supplied as complete, installed systems for healthcare environments. Buyers should verify compatibility with their facility’s water supply infrastructure and electrical requirements. Since they are reusable, installation should account for space for maintenance (e.g., filter storage, cleaning stations) and access to technical support from I3 Membrane GmbH for setup and troubleshooting.

• Do these devices include any built-in features to ensure the water meets EPA or clinical-grade purity standards?

  Yes, the i3 systems are designed to filter water to remove bacteria, aligning with EPA standards for filtered drinking water and supporting clinical-grade purity for non-sterile applications like hand washing and minor wound cleansing. While they do not produce sterile water (e.g., for surgical use), their filtration process reduces microbial contamination, making them suitable for infection control in general medical settings. Always follow manufacturer guidelines for filter replacement and system calibration to maintain performance.