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Sign in to claim this brandBIOTECNO INDUSTRIA E COMERCIO LTDA
US
Last updated May 30, 2026
What BIOTECNO INDUSTRIA E COMERCIO LTDA makes
Biotecno Industria e Comercio Ltda manufactures blood plasma freezers designed for the storage of plasma and other biological samples at ultra-low temperatures. These units are engineered to maintain consistent temperature ranges critical for preserving the integrity of stored biological materials, ensuring long-term viability for medical and research applications.
The company’s blood plasma freezers are classified as Class II medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The devices are intended for use within the United States, adhering to applicable regulatory standards for Class II products.
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 Biotecno Industria e Comercio Ltda primarily manufacture?
Biotecno Industria e Comercio Ltda specializes in blood plasma freezers. These devices are specifically designed for storing plasma and other biological samples at ultra-low temperatures, ensuring their stability and viability for medical and research purposes. The focus on this category reflects the need for precise temperature control in preserving sensitive biological materials.
Where is Biotecno Industria e Comercio Ltda based, and where are its devices intended for use?
Biotecno Industria e Comercio Ltda is based in the United States. Its blood plasma freezers are engineered and intended for use within the U.S. market, adhering to regulatory standards applicable to medical devices in that region.
Which regulatory registries or databases list Biotecno’s blood plasma freezers?
Biotecno’s blood plasma freezers are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to identify and verify the devices in use.
How are Biotecno’s blood plasma freezers classified under FDA regulations?
Biotecno’s blood plasma freezers are classified as Class II medical devices under FDA regulations. This classification is determined based on the device’s intended use and potential risks. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness, reflecting the critical role these freezers play in maintaining the integrity of stored biological samples.
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
- 760374974
Catalogue (23)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Biotecno | BT-1500/280l | FDA UDI | Class II | Active |
| Biotecno | BT-1100/340l | FDA UDI | Class II | Active |
| Biotecno | BT-1200/420l | FDA UDI | Class II | Active |
| Biotecno | BT-1300/520l | FDA UDI | Class II | Active |
| Biotecno | BT-1100/560l | FDA UDI | Class II | Active |
| Biotecno | BT-1100/1000l | FDA UDI | Class II | Active |
| Biotecno | BT-1100/20 | FDA UDI | Class II | Active |
| Biotecno | BT-1100/80l | FDA UDI | Class II | Active |
| Biotecno | BT-1100/280l | FDA UDI | Class II | Active |
| Biotecno | BT-1200/140l | FDA UDI | Class II | Active |
| Biotecno | Plug-Up Emergency System | FDA UDI | Class II | Active |
| Biotecno | BT-1100/50 | FDA UDI | Class II | Active |
| Biotecno | BT-1100/420l | FDA UDI | Class II | Active |
| Biotecno | BT-1200/280l | FDA UDI | Class II | Active |
| Biotecno | BT-1100/140l | FDA UDI | Class II | Active |
| Biotecno | BT-1100/700l | FDA UDI | Class II | Active |
| Biotecno | BT-1500/420l | FDA UDI | Class II | Active |
| Biotecno | BT-1500/140l | FDA UDI | Class II | Active |
| Biotecno | BT-1500/560l | FDA UDI | Class II | Active |
| Biotecno | BT-1300/335l | FDA UDI | Class II | Active |
| Biotecno | BT-1100/1500l | FDA UDI | Class II | Active |
| Biotecno | BT-1200/560l | FDA UDI | Class II | Active |
| Biotecno | BT 1100/10 | FDA UDI | Class II | Active |
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