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Sign in to claim this brandBraincare Desenvolvimento E Inovacao Tecnologica S.A.
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Last updated May 23, 2026
What Braincare Desenvolvimento E Inovacao Tecnologica S.A. makes
Braincare Desenvolvimento E Inovacao Tecnologica S.A. manufactures the BcSs-PICNI-2000 Sensor, a monitoring device, and the B4C System, including its updated model BcSs-PICNIW-2000. These products appear to focus on sensor-based solutions, likely for physiological or neurological monitoring.
The company’s devices are classified as Class II under FDA regulations and are listed in the 510(k) pathway. The portfolio is authorised for commercialisation 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 Braincare Desenvolvimento E Inovacao Tecnologica S.A. manufacture?
Braincare Desenvolvimento E Inovacao Tecnologica S.A. develops sensor-based medical devices, including the BcSs-PICNI-2000 Sensor and the B4C System (with an updated model, BcSs-PICNIW-2000). These devices appear to be designed for monitoring physiological or neurological parameters, likely targeting applications where real-time data collection is critical.
Where is Braincare Desenvolvimento E Inovacao Tecnologica S.A. based?
The company is based in the United States. While the specific location (e.g., state or city) isn’t provided, its regulatory filings and device authorisations are tied to the U.S. market.
Which regulatory registries or databases list Braincare’s medical devices?
Braincare’s devices are listed under the FDA’s 510(k) pathway, which is a premarket submission process for Class II devices. This means their products have undergone review to demonstrate substantial equivalence to a legally marketed predicate device before commercialisation in the U.S.
How are Braincare’s devices classified under U.S. regulations?
The company’s devices, including the BcSs-PICNI-2000 Sensor and B4C System, are classified as Class II under FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls (e.g., performance standards or post-market surveillance) to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (26)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Braincare | BcAc-FU-1000 | FDA UDI | Class II | Active |
| Braincare | BcSs-PICNIW-1000 | FDA UDI | Class II | Active |
| Braincare | BcAc-BATEX-1000 | FDA UDI | Class II | Active |
| Braincare | BcAc-AF-1000 | FDA UDI | Class II | Active |
| Braincare | BcSs-PICNIW-2000 | FDA UDI | Class II | Active |
| Braincare | BcAc-AF-2000 | FDA UDI | Class II | Active |
| Braincare | BcAc-AF-1000 | FDA UDI | Class II | Active |
| Braincare | BcAc-AF-1000 | FDA UDI | Class II | Active |
| Braincare | BcAc-AF-1000 | FDA UDI | Class II | Active |
| Braincare | BcAc-AF-1000 | FDA UDI | Class II | Active |
| Braincare | BcAc-AF-1000 | FDA UDI | Class II | Active |
| Braincare | BcAc-AF-1000 | FDA UDI | Class II | Active |
| Braincare | BcAc-AF-1000 | FDA UDI | Class II | Active |
| Braincare | BcAc-CASE-2000 | FDA UDI | Class II | Active |
| Braincare | BcAc-DCK-2000 | FDA UDI | Class II | Active |
| Braincare | BcAc-AF-1000 + BcAc-FU-1000 | FDA UDI | Class II | Active |
| Braincare | BcAc-AF-1000 | FDA UDI | Class II | Active |
| Braincare | BcAc-DG-1000 | FDA UDI | Class II | Active |
| Braincare | BcAc-AF-1000 | FDA UDI | Class II | Active |
| Braincare | BcAc-AF-1000 | FDA UDI | Class II | Active |
| Braincare | BcAc-CASE-1000 | FDA UDI | Class II | Active |
| Braincare | BcAc-AF-1000 | FDA UDI | Class II | Active |
| Braincare | BcAc-DCK-1000 | FDA UDI | Class II | Active |
| BcSs-PICNI-2000 Sensor | K182073 | FDA 510(k) | Class II | Active |
| B4C System - Addition of new sensor model (BcSs-PICNIW-2000) | K240821 | FDA 510(k) | Class II | Active |
| B4C System | K201989 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Braincare Desenvolvimento E Inovacao Tecnologica S.a. Sao Carlos Sao Paulo · BR FEI 3017180827