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US
Last updated May 23, 2026
What BIONNOVATION PRODUTOS BIOMEDICOS LTDA. makes
The company manufactures reusable surgical and dental tools, including torque wrenches for both general surgery and dental applications, as well as drill bits and depth/angle gauges for dental implantation procedures. It also produces reusable surgical screwdrivers and non-medicated surgical procedure kits for dental and maxillofacial surgeries.
These devices are classified as Class I under regulatory frameworks, with several entries listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from 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 Bionnovation Produtos Biomedicos Ltda. manufacture?
Bionnovation Produtos Biomedicos Ltda. specializes in reusable surgical and dental tools. Their product line includes torque wrenches for both general surgery and dental applications, dental implantation depth/angle gauges, pin/post dental drill bits, surgical screwdrivers, and reusable dental/maxillofacial surgical procedure kits. These tools are designed for precision in procedures like dental implants and orthopedic surgeries.
Where is Bionnovation Produtos Biomedicos Ltda. based?
The company is based in the United States. This location is relevant for regulatory compliance and distribution, as it aligns with the FDA’s jurisdiction over medical devices marketed in the U.S. and listed in the UDI database.
Which regulatory registries list Bionnovation’s devices?
Bionnovation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability for regulatory and clinical purposes.
How are Bionnovation’s devices classified under regulatory frameworks?
Bionnovation’s devices are classified as Class I under regulatory frameworks. This classification applies to low-risk devices like reusable surgical tools, torque wrenches, and dental gauges, which typically require less stringent premarket review compared to higher-risk categories.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 903266968
Catalogue (41)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bionnovation | 13017 | FDA UDI | Class I | Active |
| Bionnovation | 13061 | FDA UDI | Class I | Active |
| Bionnovation | 13118 | FDA UDI | Class I | Active |
| Bionnovation | 13057 | FDA UDI | Class I | Active |
| Bionnovation | 13032 | FDA UDI | Class I | Active |
| Bionnovation | 05055 | FDA UDI | Class I | Active |
| Bionnovation | 13053 | FDA UDI | Class I | Active |
| Bionnovation | 13259 | FDA UDI | Class I | Active |
| Bionnovation | 13054 | FDA UDI | Class I | Active |
| Bionnovation | 05084 | FDA UDI | Class I | Active |
| Bionnovation | 13136 | FDA UDI | Class I | Active |
| Bionnovation | 13052 | FDA UDI | Class I | Active |
| Bionnovation | 13133 | FDA UDI | Class I | Active |
| Bionnovation | 13051 | FDA UDI | Class I | Active |
| Bionnovation | 13049 | FDA UDI | Class I | Active |
| Bionnovation | 13138 | FDA UDI | Class I | Active |
| Bionnovation | 13129 | FDA UDI | Class I | Active |
| Bionnovation | 05057 | FDA UDI | Class I | Active |
| Bionnovation | 13019 | FDA UDI | Class I | Active |
| Bionnovation | 13108 | FDA UDI | Class I | Active |
| Bionnovation | 13135 | FDA UDI | Class I | Active |
| Bionnovation | 13127 | FDA UDI | Class I | Active |
| Bionnovation | 05097 | FDA UDI | Class I | Active |
| Bionnovation | 13066 | FDA UDI | Class I | Active |
| Bionnovation | 13085 | FDA UDI | Class I | Active |
| Bionnovation | 13059 | FDA UDI | Class I | Active |
| Bionnovation | 13106 | FDA UDI | Class I | Active |
| Bionnovation | 13132 | FDA UDI | Class I | Active |
| Bionnovation | 13010 | FDA UDI | Class I | Active |
| Bionnovation | 05085 | FDA UDI | Class I | Active |
| Bionnovation | 05116 | FDA UDI | Class I | Active |
| Bionnovation | 13130 | FDA UDI | Class I | Active |
| Bionnovation | 05088 | FDA UDI | Class I | Active |
| Bionnovation | 05086 | FDA UDI | Class I | Active |
| Bionnovation | 05053 | FDA UDI | Class I | Active |
| Bionnovation | 05051 | FDA UDI | Class I | Active |
| Bionnovation | 13065 | FDA UDI | Class I | Active |
| Bionnovation | 13139 | FDA UDI | Class I | Active |
| Bionnovation | 13021 | FDA UDI | Class I | Active |
| Bionnovation | 13107 | FDA UDI | Class I | Active |
| Bionnovation | 05073 | FDA UDI | Class I | Active |
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