FDA device listing

Depend,goodnites,Poise,Speax,Thinx

FDA device listing 1790319002 · KIMBERLY-CLARK CORPORATION

Key facts

Proprietary names Depend,goodnites,Poise,Speax,Thinx
Owner/operator KIMBERLY-CLARK CORPORATION
Owner/operator number 9001775
Product codes EYQ
Device names EYQ - Garment, Protective, For Incontinence
Device class Class I
Classification regulations (21 CFR) 876.5920
Review panels Gastroenterology & Urology
Registered establishments K-C AFC Manufacturing, S. de R.L. de C.V, Kimberly-Clark Corporation, KIMBERLY-CLARK CORPORATION, KIMBERLY-CLARK CORPORATION (BEECH ISLAND MILL), KIMBERLY-CLARK CORPORATION Cold Spring, KIMBERLY-CLARK CORPORATION PARIS PLANT, Kimberly-Clark Inc., Kimberly-Clark Vietnam Ltd.
Establishment registrations 1650783, 2184163, 9710006, 3003701733, 3005682435, 3006704694, 3009527814, 3011109575
FEI numbers 1000139864, 1000312280, 3002614014, 3003701733, 3005682435, 3006704694, 3009527814, 3011109575
Establishment operations Complaint File Establishment, Specification Developer, Foreign Exporter, Manufacturer, Repackager/Relabeler
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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