FDA Registration
Active
🇧🇷 Brazil
Braincare Wired Sensor
Reg #: 3003851947
·
FEI: 3003851947
·
Expires 2025
Products
1
Proprietary Names
12
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- APRAMED INDUSTRIA E COMERCIO DE APARELHOS MEDICOS LTDA
- Registration Number
- 3003851947
- FEI Number
- 3003851947
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- AV ANTONIO MARTINEZ CARRERA FI, 50, CEAT
- City
- SAO CARLOS Sao Paulo
- Country
- BR
Regulatory Submissions
- 510(k) Number
- K182073
Owner / Operator
- Firm Name
- APRAMED INDUSTRIA E COMERCIO DE APARELHOS MEDICOS LTDA
- Operator Number
- 9053515
- Address
- RUA ANTONIO M CARRERA FILHO, 50, 50
- City
- SAO CARLOS SAO PAULO
- State
- BR-SP
- Postal Code
- 13573420
- Country
- BR
- Correspondent
- WILSON M MAZARI
US Agent
- Business Name
- ILLUMINIX INDUSTRIES LLC 473-1068
- Contact Name
- WILSON MARCOS MAZARI
- Address
- 2219 CLAY STREET
- City
- Kissimmee
- State
- FL
- ZIP
- 34741
- Country
- US
- [email protected]
- Phone
- 516 4731068
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
Braincare Wired Sensor
Braincare Adapter Cable BcAc-MA-1027
Sensor BcSs-PICNI-2000
Adapter BcAc-MA-1028
Braincare Adapter Cable BcAc-MA-1003
Braincare Adapter Cable BcAc-MA-1028
BcSs-PICNI-2000 Sensor
Adapter BcAc-MA-1030
Adapter BcAc-MA-1003
Adapter BcAc-MA-1027
Braincare Adapter Cable BcAc-MA-1030
Braincare BcSs-PICNI- 2000 Sensor
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)