FDA Registration
Active
🇧🇷 Brazil
Ionic Health
Reg #: 3030982377
·
FEI: 3030982377
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- IONIC HEALTH TECHNOLOGIES SA
- Registration Number
- 3030982377
- FEI Number
- 3030982377
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Estrada Dr. Altino Bondensan, 500, Sala 1103 Eugenio de Melo
- City
- Sao Jose dos Campos Sao Paulo
- Country
- BR
Regulatory Submissions
- 510(k) Number
- K233660
Owner / Operator
- Firm Name
- IONIC HEALTH TECHNOLOGIES SA
- Operator Number
- 10090684
- Address
- Estrada Dr. Altino Bondensan, 500, Sala 1103 Eugenio de Melo
- City
- São José dos Campos
- State
- Sao Paulo
- Postal Code
- 12247-016
- Country
- BR
- Correspondent
- Jose L Coelho
US Agent
- Business Name
- IONIC HEALTH USA INC
- Contact Name
- Jose Coelho
- Address
- Richey Mixon Building, 11201 Cedar Ave
- City
- Cleveland
- State
- OH
- ZIP
- 44106
- Country
- US
- [email protected]
- Phone
- 216 2421223
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Tomography, Computed, Emission | KPS | Class 2 | Radiology | No | 2024-04-29 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2024-04-29 |
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2024-04-29 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2024-04-29 |
Proprietary Names
Ionic Health
Establishment Types
Manufacture Medical Device