FDA Registration
Active
🇺🇸 United States
BIOTEQUE AMERICA, INC.
Reg #: 3024860690
·
FEI: 3024860690
·
Expires 2026
Products
6
Proprietary Names
6
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- BIOTEQUE AMERICA, INC.
- Registration Number
- 3024860690
- FEI Number
- 3024860690
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1302 Exchange Drive, Suite # 150
- City
- Richardson
- State
- TX
- ZIP
- 75081
- Country
- US
Regulatory Submissions
- 510(k) Number
- K020628
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
- Gary - Liu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Curette, Suction, Endometrial (And Accessories) | HHK | Class 2 | Obstetrics/Gynecology | No | 2007-11-05 |
| Cannula, Manipulator/Injector, Uterine | LKF | Class 2 | Obstetrics/Gynecology | No | 2007-11-05 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2023-01-11 |
| Sound, Uterine | HHM | Class 1 | Obstetrics/Gynecology | No | 2023-01-11 |
| Pessary, Vaginal | HHW | Class 2 | Obstetrics/Gynecology | No | 2007-11-05 |
| Dilator, Vaginal | HDX | Class 2 | Obstetrics/Gynecology | No | 2007-11-05 |
Proprietary Names
Bioteque Curette and Preferred Curette
Bioteque HSG and SHG Catheters
Bioteque Cervical Dilators
Bioteque Uterine Sound
Bioteque Vaginal Pessaries
Bioteque Vaginal Dilators
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device