FDA Registration
Active
🇺🇸 United States
PRO-TECH DESIGN & MFG., INC.
Reg #: 2032521
·
FEI: 3003574398
·
Expires 2025
Products
7
Proprietary Names
0
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- PRO-TECH DESIGN & MFG., INC.
- Registration Number
- 2032521
- FEI Number
- 3003574398
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 14561 MARQUARDT AVE.
- City
- SANTA FE SPRINGS
- State
- CA
- ZIP
- 90670
- Country
- US
Regulatory Submissions
- PMA Number
- P880006
Owner / Operator
- Firm Name
- PRO-TECH Design & Mfg, Inc.
- Operator Number
- 9048910
- Address
- 14561 MARQUARDT AVE., --
- City
- Santa Fe Springs
- State
- CA
- Postal Code
- 90670
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implantable Pulse Generator, Pacemaker (Non-Crt) | LWP | Class 3 | Unknown | No | 2012-10-22 |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | Class 3 | Unknown | No | 2012-10-22 |
| Pulse Generator, Permanent, Implantable | NVZ | Class 3 | Unknown | No | 2012-10-22 |
| Programmer, Pacemaker | KRG | Class 3 | Cardiovascular | No | 2012-10-22 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | NKE | Class 3 | Unknown | No | 2012-10-22 |
| Implantable Pacemaker Pulse-Generator | DXY | Class 3 | Cardiovascular | No | 2012-10-22 |
| Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | NIK | Class 3 | Unknown | No | 2012-10-22 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)