Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011109575

FEI Number

3011109575

Entity Name

K-C AFC Manufacturing, S. de R.L. de C.V

City/State/Country

Nogales, Sonora Mexico, MX

Establishment Address

Calzada Industrial de las Maquiladoras # 87, Nuevo Nogales, Nogales, Sonora Mexico 84094, MX

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

KIMBERLY-CLARK CORPORATION (Owner Number: 9001775)

Owner / Operator Contact Address

1400 Holcomb Bridge Road, --, Roswell, GA 30076, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

U by Kotex U by Kotex Kotex U by Kotex Depend Speax Thinx Poise Depend goodnites

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HHW	Pessary, Vaginal	Obstetrics/Gynecology	Class 2	884.3575	2014-04-23
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2024-10-28
NRC	Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile	Obstetrics/Gynecology	Class 1	884.5425	2006-03-20
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2001-04-05
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2007-03-09

Official Correspondent

No official correspondent registered.

US Agent Details

Wioletta Bauer Business: KIMBERLY-CLARK CORPORATION Email: wioletta.bauer@kcc.com Phone: (920) 7213132

Related Public Records

Same Entity

KIMBERLY-CLARK CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9615625	KIMBERLY-CLARK PERSONAL HYGIENIC PRODUCTS CO.,LTD.BEIJING	DEVELOPMENT ZONE, BEIJING, CN
3007697999	KIMBERLY-CLARK PERU S.R.L. - Santa Clara Mill	Lima Lima (Region), PE
2184163	KIMBERLY-CLARK CORPORATION Cold Spring	NEENAH, WI, US
1650783	KIMBERLY-CLARK CORPORATION PARIS PLANT	PARIS, TX, US
3009527814	Kimberly-Clark Corporation	Ogden, UT, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K933654	Johnson & Johnson Medical, Inc.	BLADDER NECK SUPPORT PROTHESIS FITTING KIT	1995-05-04
K923985	Personal Products Co.	UNSCENTED MENSTRUAL TAMPON	1993-02-19
K151170	Tosama, D.O.O.	Tosama 100% Organic Cotton Menstrual Tampon	2015-07-02
K930149	Kimberly-Clark Corp.	KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+	1994-03-02
K823241	Kimberly-Clark Corp.	NEW FREEDOM THIN UNSCENTED MAXI PADS	1982-12-28

Similar Registrations

Registration Number	Establishment Name	Location
3031788248	WATKINS-CONTI PRODUCTS, INC	Edmond, OK, US
3015417614	RINOVUM SUBSIDIARY 2, LLC	Export, PA, US
3019039128	B&A PRECISION SILICONE RUBBER (DONGGUAN) CO., LTD	Dongguan Guangdong, CN
3014295858	COOPER MEDICAL, SRL	La Garita Alajuela, CR
3007137643	Hayden Medical Inc	Valencia, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011109575. Last updated year: 2026. Please use registration number 3011109575 when referencing this establishment in official correspondence.