FDA Registration
Active
🇧🇷 Brazil
Active Clear+
Reg #: 3003622434
·
FEI: 3003622434
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- ADITEK DO BRASIL, SA
- Registration Number
- 3003622434
- FEI Number
- 3003622434
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 25, SANTO PIERINI STREET
- City
- CRAVINHOS Sao Paulo
- Country
- BR
Regulatory Submissions
- 510(k) Number
- K160957
Owner / Operator
- Firm Name
- ADITEK DO BRASIL, SA
- Operator Number
- 9104741
- Address
- 25, SANTO PIERINI STREET, --
- City
- CRAVINHOS
- State
- Sao Paulo
- Postal Code
- 14140-000
- Country
- BR
- Correspondent
- EDUARDO - LOPES
US Agent
- Business Name
- Prime Path Medtech
- Contact Name
- Bill Jacqmein
- Address
- 811 Lakeview Drive
- City
- Shoreview
- State
- MN
- ZIP
- 55126
- Country
- US
- [email protected]
- Phone
- 404 2166190
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bracket, Ceramic, Orthodontic | NJM | Class 2 | Dental | No | 2018-05-11 |
Proprietary Names
Active Clear+
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device