FDA Registration
Active
🇧🇷 Brazil
Bone Cement - Normal Viscosity
Reg #: 3009685086
·
FEI: 3009685086
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIOMECANICA INDUSTRIA E COMERCIO DE PRODUTOS ORTOPEDICOS LTDA
- Registration Number
- 3009685086
- FEI Number
- 3009685086
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Rua Luiz Pengo 145
- City
- Jau Sao Paulo
- Country
- BR
Regulatory Submissions
- 510(k) Number
- K212729
Owner / Operator
- Firm Name
- Biomecanica Industria e Comercio de Produtos Ortopedicos Ltd
- Operator Number
- 10093117
- Address
- Rua Luiz Pengo 145
- City
- Jau
- State
- Sao Paulo
- Postal Code
- 17212811
- Country
- BR
- Correspondent
- Melina M Roncada
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 |
|---|---|---|---|---|---|
| Bone Cement | LOD | Class 2 | Orthopedic | No | 2025-04-01 |
Proprietary Names
Bone Cement - Normal Viscosity
Establishment Types
Manufacture Medical Device