FDA Registration
Active
🇧🇪 Belgium
Ontex BV
Reg #: 3010692191
·
FEI: 3010692191
·
Expires 2026
Products
3
Proprietary Names
0
Establishment Types
3
Classifications
3
Registration Details
- Registration Name
- Ontex BV
- Registration Number
- 3010692191
- FEI Number
- 3010692191
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5 Genthof
- City
- Buggenhout Oost-Vlaanderen
- Country
- BE
Regulatory Submissions
- 510(k) Number
- K914430
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
US Agent
- Business Name
- Valor Brands LLC
- Contact Name
- Kyna Smith
- Address
- 5900 Windward Parkway, Suite100
- City
- Alpharetta
- State
- GA
- ZIP
- 30005
- Country
- US
- [email protected]
- Phone
- 770 3469250
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tampon, Menstrual, Unscented | HEB | Class 2 | Obstetrics/Gynecology | No | 2008-07-10 |
| 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 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device