RegWardenFDA facility compliance records
Facility

HIDREX GMBH

1 recall(s) on record — most severe on record: Class III.

Activity by year

FDA actions on record by year2017: 1 recalls; 2023: 1 inspections120172018201920202021202212023202420252026
  • Recalls (1)
  • Inspections (1)

Devices registered here (1)

  • Device, Iontophoresis, Other Uses
    Product code EGJ (opens in a new tab) · Class II · Physical Medicine · 21 CFR 890.5525

Recalls & enforcement

  • Class IIITerminated2017-01-30
    The device was reclassified from a class III device to a class II device and there are new documentation requirements.

FDA inspections (1)

  • OAI2023-11-09
    Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “HIDREX GMBH (FEI 3008642982) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008642982-hidrex-gmbh/

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