FDA Registration
Active
🇺🇸 United States
CPE1, LLC DBA Greatbatch Medical
Reg #: 3017168767
·
FEI: 3017168767
·
Expires 2026
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- CPE1, LLC DBA Greatbatch Medical
- Registration Number
- 3017168767
- FEI Number
- 3017168767
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 19700 Stirling Road, Suite 1
- City
- Southwest Ranches
- State
- FL
- ZIP
- 33332
- Country
- US
Owner / Operator
- Firm Name
- Integer
- Operator Number
- 10091663
- Address
- 19700 Stirling Road, Suite 1
- City
- Southwest Ranches
- State
- FL
- Postal Code
- 33332
- Country
- US
- Correspondent
- Mariela Martinez
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2024-10-22 |
| Catheter, Percutaneous, Neurovasculature | QJP | Class 2 | Cardiovascular | No | 2024-10-22 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2025-08-29 |
| Catheter, Thrombus Retriever | NRY | Class 2 | Cardiovascular | No | 2024-10-22 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2024-10-22 |
Proprietary Names
CPE1, LLC DBA Greatbatch Medical
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)