Data / Medical devices / Germany / i3 Membrane GmbH
i3 Membrane GmbH: FDA-registered device maker in Radeberg Saxony, Germany, 1 510(k) clearance
i3 Membrane GmbH is registered with the FDA (registration 3022699154) in Radeberg Saxony, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 2, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022699154
- Address
- Christoph-Seydel-Strasse 1, Radeberg Saxony, Germany, 01454
- Owner or operator
- i3 Membrane GmbH (10088961)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 25, 2023
- Registered through
- 2026
- Brand names listed
- i3 ONE, i3 TWO connect, i3 TWO direct
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Water Purification, General Medical Use | NHV | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 2, 2023 | K222727 | i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) | NHV | Substantially Equivalent | I3 Membrane GmbH | accessdata.fda.gov |
Compare with other makers
Updated June 2, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.