FDA Registration
Active
🇺🇸 United States
BIOTEX, INC.
Reg #: 3005726841
·
FEI: 3005726841
·
Expires 2026
Products
7
Proprietary Names
6
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- BIOTEX, INC.
- Registration Number
- 3005726841
- FEI Number
- 3005726841
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 114 Holmes Rd
- City
- HOUSTON
- State
- TX
- ZIP
- 77045
- Country
- US
Regulatory Submissions
- 510(k) Number
- K203712
Owner / Operator
- Firm Name
- BIOTEX, INC.
- Operator Number
- 9079181
- Address
- 114 Holmes Rd, --
- City
- Houston
- State
- TX
- Postal Code
- 77045
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Jaw Repositioning | LQZ | Class 2 | Dental | No | 2021-08-19 |
| Device, Anti-Snoring | LRK | Class 2 | Dental | No | 2021-08-19 |
| Lamp, Surgical | FTD | Class 2 | General, Plastic Surgery | No | 2019-06-27 |
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2024-08-12 |
| Pump, Air, Non-Manual, For Endoscope | FEQ | Class 2 | Gastroenterology, Urology | No | 2024-08-12 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2025-02-20 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2023-02-07 |
Proprietary Names
The Slide
SurgiLux
troCarWash System
troCarWash Automated Visualization System
Slide Bite Fork
Wire Watch
Establishment Types
Manufacture Medical Device