FDA Registration
Active
🇧🇷 Brazil
Adapter BcAc-MA-1003
Reg #: 3017180827
·
FEI: 3017180827
·
Expires 2025
Products
1
Proprietary Names
13
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA S.A.
- Registration Number
- 3017180827
- FEI Number
- 3017180827
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Av Bruno Ruggiero Filho, 971
- City
- Sao Carlos Sao Paulo
- Country
- BR
Regulatory Submissions
- 510(k) Number
- K182073
Owner / Operator
- Firm Name
- Braincare Desenvolvimento e Inovacao Tecnologica S.A.
- Operator Number
- 10061705
- Address
- Av Bruno Ruggiero Filho, 971
- City
- São Carlos
- State
- Sao Paulo
- Postal Code
- 13562-420
- Country
- BR
- Correspondent
- Arnaldo Betta
US Agent
- Business Name
- Braincare USA Corp
- Contact Name
- Claudio Menegusso
- Address
- 6470 E Johns Xing Ste 160 Ofc 114
- City
- Johns Creek
- State
- GA
- ZIP
- 30097
- Country
- US
- [email protected]
- Phone
- 424 8882942
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Monitoring, Intracranial Pressure | GWM | Class 2 | Neurology | No | 2020-07-01 |
Proprietary Names
Adapter BcAc-MA-1003
Braincare Adapter Cable BcAc-MA-1030
Adapter BcAc-MA-1030
Braincare Wired Sensor
Adapter BcAc-MA-1027
Braincare Adapter Cable BcAc-MA-1003
Sensor BcSs-PICNI-2000
BcSs-PICNI-2000 Sensor
Braincare BcSs-PICNI- 2000 Sensor
Braincare Wired System Headband Set
Braincare Adapter Cable BcAc-MA-1027
Adapter BcAc-MA-1028
Braincare Adapter Cable BcAc-MA-1028
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device