FDA Registration
Active
🇲🇽 Mexico
Gynesonics, Inc.
Reg #: 3016096098
·
FEI: 3016096098
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- CENTERPIECE S. DE R.L DE C.V
- Registration Number
- 3016096098
- FEI Number
- 3016096098
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Avenidad de la Hospitalidad #505, Lucio Blanco
- City
- Playas de Rosarito Baja California
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K250705
Owner / Operator
- Firm Name
- Centerpiece Holdings LLC
- Operator Number
- 10061801
- Address
- 420 Stevens Ave, Suite 230
- City
- Solana Beach
- State
- CA
- Postal Code
- 92075
- Country
- US
- Correspondent
- JEFF HOVER
US Agent
- Business Name
- Global Director QA/RA
- Contact Name
- Raza Mohammed
- Address
- 300 Great Oaks Blvd Ste 325
- City
- Albany
- State
- NY
- ZIP
- 12203
- Country
- US
- [email protected]
- Phone
- 443 5545486
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2025-07-10 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2025-07-10 |
| Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | KNF | Class 2 | Obstetrics/Gynecology | No | 2025-07-10 |
Proprietary Names
Gynesonics, Inc.
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)