FDA Registration
Active
🇺🇸 United States
Bioteque Vaginal Pessaries
Reg #: 3024860690
·
FEI: 3024860690
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- BIOTEQUE AMERICA, INC.
- Registration Number
- 3024860690
- FEI Number
- 3024860690
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1302 Exchange Drive, Suite # 150
- City
- Richardson
- State
- TX
- ZIP
- 75081
- Country
- US
Regulatory Submissions
- 510(k) Number
- K013289
Owner / Operator
- Firm Name
- Bioteque America, Inc.
- Operator Number
- 9053395
- Address
- 1302 Exchange Drive., Suite#150
- City
- Richardson
- State
- TX
- Postal Code
- 75081
- Country
- US
- Correspondent
- Bioteque - America
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pessary, Vaginal | HHW | Class 2 | Obstetrics/Gynecology | No | 2007-11-05 |
Proprietary Names
Bioteque Vaginal Pessaries
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device