FDA Registration
Active
🇩🇴 Dominican Republic
EDGE, EVOTEC, LUMBITEC, OASIS SOFT, PRIMO, SALO, STEALTH, STOCK MINERVA ATTACHMENTS, STOCK STERNAL PAD KIT
Reg #: 3011528799
·
FEI: 3011528799
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OPTEC USA, INC
- Registration Number
- 3011528799
- FEI Number
- 3011528799
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- SOLAR 3, MANZANA 2-B, ZONA FRANCA INDUSTRIAL SAN PEDRO DE MACORIS
- City
- SAN PEDRO DE MACORIS
- Country
- DO
Owner / Operator
- Firm Name
- OPTEC USA, INC.
- Operator Number
- 9033352
- Address
- 975 PROGRESS CIRCLE, --
- City
- Lawrenceville
- State
- GA
- Postal Code
- 30043
- Country
- US
- Correspondent
- Daniel - Suarez
US Agent
- Business Name
- Optec USA, Inc.
- Contact Name
- NEHEMIAH J. SUAREZ
- Address
- 975 Progress Circle
- City
- Lawrenceville
- State
- GA
- ZIP
- 30043
- Country
- US
- [email protected]
- Phone
- 770 5137380
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2004-02-11 |
Proprietary Names
EDGE, EVOTEC, LUMBITEC, OASIS SOFT, PRIMO, SALO, STEALTH, STOCK MINERVA ATTACHMENTS, STOCK STERNAL PAD KIT
ORTHOSIS LUMBO-SACRAL
Establishment Types
Repack or Relabel Medical Device