FDA Registration
Active
🇺🇸 United States
Ontex Operations USA, LLC
Reg #: 3019545200
·
FEI: 3019545200
·
Expires 2026
Products
4
Proprietary Names
0
Establishment Types
3
Classifications
4
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Registration Details
- Registration Name
- Ontex Operations USA, LLC
- Registration Number
- 3019545200
- FEI Number
- 3019545200
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9300 NC HWY 65
- City
- Stokesdale
- State
- NC
- ZIP
- 27357
- Country
- US
Owner / Operator
- Firm Name
- Ontex Mexico Operations S.A de C.V
- Operator Number
- 9036701
- Address
- Calle Doce Norte 105, Ciudad Industrial
- City
- Tijuana
- State
- Baja California
- Postal Code
- 22444
- Country
- MX
- Correspondent
- Cecilia Guadalupe Jimenez Rodriguez
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2003-02-27 |
| Pad, Menstrual, Unscented | HHD | Class 1 | Obstetrics/Gynecology | No | 2006-09-21 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2020-08-11 |
| Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile | NRC | Class 1 | Obstetrics/Gynecology | No | 2020-08-11 |
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device