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Sign in to claim this brandBIOTEQUE AMERICA, INC.
US
Last updated September 17, 2026
What BIOTEQUE AMERICA, INC. makes
Bioteque America, Inc. manufactures medical devices for pelvic health, including pessaries designed to support pelvic organs, vaginal dilators for therapeutic use, and endometrial biopsy kits for tissue sampling. These products are intended for clinical applications in gynecological and reproductive health settings.
The company’s portfolio consists of Class II devices, which are regulated under the FDA’s 510(k) and Unique Device Identification (UDI) programs. These devices are listed in the FDA’s regulatory databases, and the manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Bioteque America, Inc. manufacture?
Bioteque America, Inc. specializes in medical devices focused on pelvic health. Their primary products include pelvic-organ-supporting pessaries, which provide structural support to pelvic organs, vaginal dilators used therapeutically to improve pelvic floor function, and endometrial biopsy kits designed for obtaining tissue samples from the uterine lining. These devices are developed for clinical use in gynecological and reproductive health settings.
Where is Bioteque America, Inc. based, and how does that affect its regulatory standing?
Bioteque America, Inc. is headquartered in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including mandatory compliance with the 510(k) premarket notification process and the Unique Device Identification (UDI) system. These requirements ensure traceability and safety assessments for Class II devices, which are the classification for Bioteque’s products.
Which regulatory registries or databases list Bioteque America, Inc.’s devices?
Bioteque America, Inc.’s devices are included in the FDA’s 510(k) database and the FDA’s Unique Device Identifier (UDI) system. These registries track Class II devices like those produced by Bioteque, ensuring transparency in their regulatory clearance status and compliance with U.S. medical device laws. The listings confirm the devices meet FDA requirements for safety and effectiveness.
How are Bioteque America, Inc.’s devices classified under FDA regulations?
Bioteque America, Inc.’s devices fall under FDA Class II classification. This classification applies to devices that generally pose moderate risk and require special controls beyond general controls to ensure their safety and performance. Class II devices like those manufactured by Bioteque are subject to 510(k) premarket submissions and UDI requirements, demonstrating they undergo rigorous review before entering the market.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 1302 Exchange Drive, Suite # 150, Richardson, TX, 75081
- Website
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3024860690
- DUNS Number
- —
Catalogue (243)
Page 5 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bioteque America, Inc. | DT-A/M | FDA UDI | Class II | Active |
| Bioteque America, Inc. | FS9000 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | M5 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | DT-A | FDA UDI | Class II | Active |
| Bioteque America, Inc. | Gd4 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | IR0 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | D4 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | Rs5 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | RK1 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | CP5 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | R7 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | OVs8 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | GS4 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | HDs7 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | Gd1 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | OV4 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | HD4 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | RKs6 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | CPs7 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | R0 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | HD5 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | Ms8 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | CPs5 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | DSH7 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | RK5 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | HD2 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | HDs0 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | HDs1 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | Rs1 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | M4 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | DSHs0 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | IR1 | FDA UDI | Class II | Active |
| Bioteque America, Inc. | OV1 | FDA UDI | Class II | Active |
| Bioteque Vaginal Dilator | K003380 | FDA 510(k) | Class II | Active |
| Speculum | K933521 | FDA 510(k) | Class II | Active |
| Versa-Vial | K920177 | FDA 510(k) | Class II | Active |
| Flexible Silicone Gelihorn | K920187 | FDA 510(k) | Class II | Active |
| Cytology Brush | K933628 | FDA 510(k) | Class II | Active |
| Pessary Flexible Silicone Nichols | K920633 | FDA 510(k) | Class II | Active |
| Hsg Catheter Set | K041094 | FDA 510(k) | Class II | Active |
| Pessary Flexible Silicone Donut Ring | K920747 | FDA 510(k) | Class II | Active |
| Bioteque Vaginal Pessaries | K013289 | FDA 510(k) | Class II | Active |
| Curelle, Preferred Curelle, Cuteq 2.5 | K020628 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Bioteque America, Inc. has one FDA recall record initiated on February 24, 2005, which is listed with a terminated status. The recall was due to the product being marketed without a required 510(k) clearance.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 24, 2005 | Z-0027-05 | — | terminated | product is marketed without a 510(k) |