Data / Medical devices / Mexico / K-C AFC Manufacturing, S. de R.L. de C.V
K-C AFC Manufacturing, S. de R.L. de C.V: FDA-registered device maker in Nogales, Sonora Mexico, Mexico, 2 510(k) clearances
K-C AFC Manufacturing, S. de R.L. de C.V is registered with the FDA (registration 3011109575) in Nogales, Sonora Mexico, Mexico. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 6, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011109575
- Address
- Calzada Industrial de las Maquiladoras # 87 Nuevo Nogales, Nogales, Sonora Mexico, Mexico, 84094
- Owner or operator
- KIMBERLY-CLARK CORPORATION (9001775)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- April 5, 2001
- Registered through
- 2026
- Brand names listed
- Depend, Kotex, Poise, Speax, Thinx, U by Kotex, goodnites
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Garment, Protective, For Incontinence | EYQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile | NRC | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tampon, Menstrual, Unscented | HEB | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 6, 2023 | K223749 | U by Kotex® Click® Unscented Menstrual Tampons | HEB | Substantially Equivalent | Kimberly-Clark Corporation | accessdata.fda.gov |
| October 11, 2017 | K172118 | U by Kotex Click Unscented Menstrual Tampons | HEB | Substantially Equivalent | Kimberly-Clark Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Garment, Protective, For Incontinence
- All makers of Tampon, Menstrual, Unscented
- All makers of Pad, Menstrual, Unscented
- All makers of Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile
Updated January 6, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.