FDA Registration
Active
🇧🇷 Brazil
Neurodn II
Reg #: 3010362721
·
FEI: 3010362721
·
Expires 2025
Products
3
Proprietary Names
4
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Ibramed Industria Brasileira de Equipamentos Medicos Ltda
- Registration Number
- 3010362721
- FEI Number
- 3010362721
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Ave Dr. Carlos Burgos 2800, Jardim Italia
- City
- Amparo Sao Paulo
- Country
- BR
Regulatory Submissions
- 510(k) Number
- K131917
Owner / Operator
- Firm Name
- Ibramed Industria Brasileira de Equipamentos Medicos Ltda
- Operator Number
- 10043478
- Address
- Ave Dr. Carlos Burgos 2800, Jardim Italia
- City
- Amparo
- State
- Sao Paulo
- Postal Code
- 13901-080
- Country
- BR
- Correspondent
- Ricardo Souza
US Agent
- Business Name
- United Regulatory & Logistics LLC
- Contact Name
- Rodrigo Abreu
- Address
- 2950 W Cypress Creek Rdd #110
- City
- Fort Lauderdale
- State
- FL
- ZIP
- 33309
- Country
- US
- [email protected]
- Phone
- 786 2667900
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Neuromuscular, External Functional | GZI | Class 2 | Neurology | No | 2014-05-19 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2014-05-19 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2014-05-19 |
Proprietary Names
Neurodn II
Neurodyn Compact
NEUROTONUS Compact
NEUROTONUS II
Establishment Types
Manufacture Medical Device