Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022699154

FEI Number

3022699154

Entity Name

i3 Membrane GmbH

City/State/Country

Radeberg Saxony, DE

Establishment Address

Christoph-Seydel-Strasse 1, Radeberg Saxony 01454, DE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

i3 Membrane GmbH (Owner Number: 10088961)

Owner / Operator Contact Address

Theodorstrasse 41P, Hamburg, DE-HH 22761, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222727

PMA Number

N/A

All Registered Proprietary Names

i3 TWO direct i3 TWO connect i3 ONE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHV	System, Water Purification, General Medical Use	Gastroenterology, Urology	Class 2	876.5665	2023-10-25

Official Correspondent

Hauke Tammena

US Agent Details

Kenneth Renfrew Business: i3 Membrane Corporation Email: k.renfrew@i3membrane.com Phone: (980) 8888117

Related Public Records

Same Entity

i3 Membrane GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022699154. Last updated year: 2026. Please use registration number 3022699154 when referencing this establishment in official correspondence.