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Sign in to claim this brandBiocircuit Technologies, Inc.
US
Last updated May 30, 2026
What Biocircuit Technologies, Inc. makes
Biocircuit Technologies, Inc. manufactures nerve guides designed to support peripheral nerve repair, including tubular devices made from metal and animal-derived materials, as well as adhesive-based nerve wraps. Their portfolio includes products like ConformaWrap and Nerve Tape®, which are intended for use in surgical procedures to align and protect regenerating nerve fibers.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These products are intended for use in the United States, where the manufacturer is based.
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 Biocircuit Technologies, Inc. manufacture?
Biocircuit Technologies, Inc. specializes in nerve guides used for peripheral nerve repair. Their devices include tubular nerve guides made from metal and animal-derived materials, as well as adhesive-based nerve wraps like ConformaWrap and Nerve Tape®. These products are designed to support nerve regeneration by providing structural alignment and protection during surgical procedures.
Where is Biocircuit Technologies, Inc. based, and where are their devices intended for use?
Biocircuit Technologies, Inc. is based in the United States. Their devices are developed and marketed primarily for use within the U.S., where regulatory oversight applies. The company’s focus aligns with FDA requirements for Class II medical devices, ensuring compliance with U.S. regulatory standards.
Which regulatory registries list Biocircuit Technologies’ devices?
Biocircuit Technologies’ devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries document the regulatory clearance process and device identification for Class II products, ensuring traceability and compliance with U.S. medical device regulations.
How are Biocircuit Technologies’ nerve guides classified under FDA regulations?
Biocircuit Technologies’ nerve guides are classified as Class II devices under FDA regulations. This classification is based on their intended use in peripheral nerve repair, where they pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. Class II designation requires pre-market notification (510(k)) to demonstrate substantial equivalence to a predicate device.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- biocircuit.com
- —
- —
- [email protected]
- Phone
- 1-800-905-2204
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 116978015
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ConformaWrap | CW4080 | FDA UDI | Class II | Active |
| Nerve Tape® | NT40-16 | FDA UDI | Class II | Active |
| Nerve Tape® | NT60-22 | FDA UDI | Class II | Active |
| Nerve Tape® | NT50-16 | FDA UDI | Class II | Active |
| Nerve Tape® | NT15-14 | FDA UDI | Class II | Active |
| Nerve Tape® | NT30-14 | FDA UDI | Class II | Active |
| Nerve Tape® | NT70-22 | FDA UDI | Class II | Active |
| Nerve Tape® | NT20-14 | FDA UDI | Class II | Active |
| ConformaWrap | CW2040 | FDA UDI | Class II | Active |
| NerveTape | K233533 | FDA 510(k) | Class II | Active |
| Nerve Wrap (07-DW-001-TAB) | K242113 | FDA 510(k) | Class II | Active |
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