FDA Registration
Active
🇺🇸 United States
CONTEX, INCORPORATED
Reg #: 2031102
·
FEI: 2017777
·
Expires 2026
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- CONTEX, INCORPORATED
- Registration Number
- 2031102
- FEI Number
- 2017777
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4505 VAN NUYS BLVD.
- City
- SHERMAN OAKS
- State
- CA
- ZIP
- 91403
- Country
- US
Regulatory Submissions
- 510(k) Number
- K001960
- PMA Number
- P010062
Owner / Operator
- Firm Name
- Contex, Incorporated
- Operator Number
- 9012202
- Address
- 4505 VAN NUYS BLVD., --
- City
- Sherman Oaks
- State
- CA
- Postal Code
- 91403
- Country
- US
- Correspondent
- Steven P Ernst
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lens, Contact (Other Material) - Daily | HQD | Class 2 | Ophthalmic | No | 2014-01-20 |
| Lens, Contact (Orthokeratology) | MUW | Class 2 | Ophthalmic | No | 2014-01-20 |
| Lens, Contact, Orthokeratology, Overnight | NUU | Class 3 | Ophthalmic | No | 2014-01-20 |
| Lens, Contact (Rigid Gas Permeable), Extended Wear | MWL | Class 3 | Ophthalmic | No | 2014-01-20 |
Proprietary Names
Contex OK Lens
Establishment Types
Manufacture Medical Device