FDA Registration
Active
🇧🇷 Brazil
Etherea
Reg #: 3007085226
·
FEI: 3007085226
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Vydence Medical Industria e Comercio Ltda
- Registration Number
- 3007085226
- FEI Number
- 3007085226
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Rua Aldo Germano Klein, 359, CEP: 13.573-470 - Caixa Postal 772
- City
- CEAT - Sao Carlos/SP Sao Paulo
- Country
- BR
Regulatory Submissions
- 510(k) Number
- K112505
Owner / Operator
- Firm Name
- Vydence Medical Industria e Comercio Ltda
- Operator Number
- 10040501
- Address
- Rua Aldo Germano Klein, 359, CEP: 13.573-470 - Caixa Postal 772
- City
- CEAT - Sao Carlos
- State
- Sao Paulo
- Postal Code
- 34446
- Country
- BR
- Correspondent
- Eduardo Alves Gabriel
US Agent
- Business Name
- Hoy & Associates Regulatory Consulting LLC
- Contact Name
- Connie Hoy
- Address
- 1830 Bonnie Way
- City
- Sacramento
- State
- CA
- ZIP
- 95825
- Country
- US
- [email protected]
- Phone
- 530 9084903
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2012-04-20 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2012-04-20 |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | Class 2 | General, Plastic Surgery | No | 2012-04-20 |
Proprietary Names
Etherea
Establishment Types
Manufacture Medical Device