FDA Registration
Active
🇺🇸 United States
CALATEX, INC.
Reg #: 2084177
·
FEI: 2084177
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CALATEX, INC.
- Registration Number
- 2084177
- FEI Number
- 2084177
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1607 E McFadden Ave Ste H
- City
- Santa Ana
- State
- CA
- ZIP
- 92705
- Country
- US
Regulatory Submissions
- 510(k) Number
- K150857
Owner / Operator
- Firm Name
- CALATEX, INC.
- Operator Number
- 9000397
- Address
- 1607 E McFadden Ave, Unit H, --
- City
- Santa Ana
- State
- CA
- Postal Code
- 92705
- Country
- US
- Correspondent
- DUKEE - KWON
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Condom | HIS | Class 2 | Obstetrics/Gynecology | No | 2015-11-20 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)