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MaxiNeb BAN 032-10-201U

by Enchant Tek. Co, Ltd.

MaxiNeb BAN 032-10-201U is a therapeutic agent nebulizer (FDA Class II; FDA product code CAF, Nebulizer (Direct Patient Interface)) made by Enchant Tek. Co, Ltd., cleared under FDA 510(k) K242354 on 29 Apr 2025 and listed in FDA GUDID since 28 May 2026 (UDI-DI 04719882305016), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K242354

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04719882305016 UDI-DI Date28 May 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK242354 Date29 Apr 2025IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K242354 decided 29 Apr 2025 Active
  • FDA GUDID UDI-DI 04719882305016 listed 28 May 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K242354
  2. Listed FDA GUDID 04719882305016

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MaxiNeb BAN
Generic name
Therapeutic agent nebulizer, benchtop
Model / Ref / Catalog
032-10-201U
Primary DI / UDI-DI
04719882305016
510(k) Number
FDA product code
CAF
GMDN term
Therapeutic agent nebulizer, benchtop
Device class
Class II
Regulation number
868.5630
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code CAF (Nebulizer (Direct Patient Interface)).

Other devices from Enchant Tek. Co, Ltd.

  • MaxiPEP 032-10-301U

    Class II

  • AllNEB

    Class IIa

  • AllPEP

    Class IIa

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)