FDA Registration
Active
🇧🇷 Brazil
Therapy XT
Reg #: 3035375032
·
FEI: 3035375032
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDA
- Registration Number
- 3035375032
- FEI Number
- 3035375032
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Rua Sebastiao de Moraes 831 - Jd Santa Felicia
- City
- Sao Carlos Sao Paulo
- Country
- BR
Regulatory Submissions
- 510(k) Number
- K232813
Owner / Operator
- Firm Name
- DMC Importacao e Exportacao de Equipamentos Ltda
- Operator Number
- 10092439
- Address
- Rua Sebastiao de Moraes 831 - Jd Santa Felicia
- City
- Sao Carlos
- State
- Sao Paulo
- Postal Code
- 13562-030
- Country
- BR
US Agent
- Business Name
- Passarini Regulatory Affairs of America LLC
- Contact Name
- Lucas Rodrigues
- Address
- 10185 Henbury St
- City
- Orlando
- State
- FL
- ZIP
- 32832
- Country
- US
- [email protected]
- Phone
- 786 8496760
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | NHN | Class 2 | Physical Medicine | No | 2025-01-08 |
Proprietary Names
Therapy XT
Therapy EC
Establishment Types
Manufacture Medical Device