Contract manufacturerOntex Operations USA, LLC (Stokesdale, NC)North CarolinaGastroenterology and urologyObstetrics and gynecologyClass I
Ontex Operations USA, LLC
Contract manufacturer ยท Stokesdale, NC
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3019545200 (openFDA record; or search FDA's registration database)
- FEI number
- 3019545200
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- Ontex BV (FDA owner/operator no. 9036701)
- Registered address
- 9300 NC HWY 65, Stokesdale, NC 27357
- Contract listings
- 3 device listings, 3 product codes, first listed Feb 27, 2003
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| EYQ | Garment, Protective, For Incontinence | Class I | Gastroenterology and urology | Contract manufacturing | Feb 27, 2003 |
| HHD | Pad, Menstrual, Unscented | Class I | Obstetrics and gynecology | Contract manufacturing | Sep 21, 2006 |
| NRC | Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile | Class I | Obstetrics and gynecology | Contract manufacturing | Aug 11, 2020 |