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Sign in to claim this brandBIOVISION TECHNOLOGIES, LLC
US
Last updated May 24, 2026
What BIOVISION TECHNOLOGIES, LLC makes
Biovision Technologies, LLC manufactures endoscopic video imaging systems designed for minimally invasive procedures, including flexible and needle-based scopes. Their product line includes ultra-thin scopes like the 1.2mm InnerVue II and various NeedleView scopes with different angles and lengths, as well as disposable scope kits for single-use applications. These devices are used in specialized medical fields such as interventional radiology, urology, and ENT for precise visualization during procedures.
The company’s endoscopic video imaging systems are classified as Class II medical devices under FDA regulations. These devices are authorised through the 510(k) premarket notification process and are listed in the FDA’s Unique Device Identifier (UDI) database. Biovision Technologies, LLC 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 Biovision Technologies, LLC primarily manufacture?
Biovision Technologies, LLC specializes in endoscopic video imaging systems, particularly those used for minimally invasive procedures. Their product line includes ultra-thin flexible scopes like the 1.2mm InnerVue II and needle-based scopes (e.g., NeedleView series) with varying angles and lengths. These devices are designed for precise visualization in specialized fields such as interventional radiology, urology, and ENT.
Where is Biovision Technologies, LLC based, and how does this affect its regulatory standing?
Biovision Technologies, LLC is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA’s 510(k) premarket notification process and UDI database listing are key frameworks used to authorize and track these Class II devices, ensuring compliance with U.S. medical device standards.
How are Biovision Technologies, LLC’s devices classified under FDA regulations, and why does this matter?
Biovision Technologies, LLC’s endoscopic video imaging systems fall under Class II classification by the FDA. This classification indicates moderate risk, requiring special controls beyond general controls to ensure safety and effectiveness. Class II devices must undergo the 510(k) premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device, ensuring they meet regulatory requirements before authorization.
Which regulatory registries or databases list Biovision Technologies, LLC’s devices, and what is their purpose?
Biovision Technologies, LLC’s devices are listed in the FDA’s 510(k) database and the FDA’s Unique Device Identifier (UDI) database. The 510(k) database tracks devices authorized through the premarket notification process, while the UDI database provides a standardized identifier system for tracking devices throughout their lifecycle—from manufacturing to post-market surveillance. These registries help ensure transparency, traceability, and compliance with U.S. medical device regulations.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- biovisiontech.com
- —
- —
- [email protected]
- Phone
- 303-237-9608
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 166160106
Catalogue (15)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 1.2mm InnerVue II Scope Kit | 922180 | FDA UDI | Class II | Active |
| NeedleCam HD System | BVT01197-00001 | FDA UDI | Class II | Active |
| OnPoint Disposable Scope Kit | 24-3000 | FDA UDI | Class II | Active |
| InnerVue II 100mm Scope Kit | 922142 | FDA UDI | Class II | Active |
| NeedleView 10 Degree 100mm Scope Kit | BVTKIT72-1R1A0 | FDA UDI | Class II | Active |
| OnPoint Lite System | 24-4200 | FDA UDI | Class II | Active |
| NeedleView 0 Degree 100mm Scope Kit | BVTKIT72-0L1A0 | FDA UDI | Class II | Active |
| NeedleView 30 Degree 100mm Scope Kit | BVTKIT75-3R1A0 | FDA UDI | Class II | Active |
| NeedleView 10 Degree 65mm Scope Kit | BVTKIT72-1R165 | FDA UDI | Class II | Active |
| NeedleView CH Scope Kit | BVTKIT82-34001 | FDA UDI | Class II | Active |
| NeedleView 30 Degree 65mm Scope Kit | BVTKIT75-3R165 | FDA UDI | Class II | Active |
| NeedleView 0 Degree 65mm Scope Kit | BVTKIT72-0L165 | FDA UDI | Class II | Active |
| Needle View Ch Scope Kits | K141326 | FDA 510(k) | Class II | Active |
| Surgview Integrated Visualization System | K082293 | FDA 510(k) | Class II | Active |
| NeedleCam HD Visualization System | K143705 | FDA 510(k) | Class II | Active |
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