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i3 ONE 203100-S

by i3 Membrane GmbH

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04260632190159 UDI-DI Date31 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
i3 ONE
Generic Name
Microbial water purification filter, non-sterilizable
Model / Reference
203100-S
Primary DI / UDI-DI
04260632190159
510(k) Number
FDA Product Code
NHV
GMDN Term
Microbial water purification filter, non-sterilizable
Device Class
Class II
Regulation Number
876.5665
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K222727)

Other devices from i3 Membrane GmbH

Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Manufacturing Date: No