Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017180827

FEI Number

3017180827

Entity Name

BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA S.A.

City/State/Country

Sao Carlos Sao Paulo, BR

Establishment Address

Av Bruno Ruggiero Filho, 971, Sao Carlos Sao Paulo 13562-420, BR

Establishment Type(s)

Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Braincare Desenvolvimento e Inovacao Tecnologica S.A. (Owner Number: 10061705)

Owner / Operator Contact Address

Av Bruno Ruggiero Filho, 971, São Carlos, BR-SP 13562-420, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240821

PMA Number

N/A

All Registered Proprietary Names

B4C System - Wireless Sensor (Model: BCSs-PICNIW-2000) B4C System B4C System - Wireless Sensor Headband (Model: BcAc-AF-2000) B4C System - Wireless Sensor Charger (Model: BcAc-DCK-2000) B4C System - Addition of new sensor model (BcSs-PICNIW-2000) B4C System - Wireless Adapter (Model: BcAc-DG-1000) B4C System - Plastic casing (Model: BcAc-CASE-2000)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2024-07-30

Official Correspondent

Arnaldo Betta

US Agent Details

Claudio Menegusso Business: Braincare USA Corp Email: claudio.menegusso@brain4.care Phone: (424) 8882942

Related Public Records

Same Entity

Braincare Desenvolvimento e Inovacao Tecnologica S.A.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3023074935	Braincare USA Corp.	Johns Creek, GA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K020558	Integra Neurosciences	LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE	2002-03-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017180827. Last updated year: 2026. Please use registration number 3017180827 when referencing this establishment in official correspondence.