Contract manufacturerCPE1, LLC DBA Greatbatch Medical (Southwest Ranches, FL)FloridaCardiovascularClass II
CPE1, LLC DBA Greatbatch Medical
Contract manufacturer · Southwest Ranches, FL
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3017168767 (openFDA record; or search FDA's registration database)
- FEI number
- 3017168767
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Integer (FDA owner/operator no. 10091663)
- Registered address
- 19700 Stirling Road, Suite 1, Southwest Ranches, FL 33332
- Contract listings
- 7 device listings, 5 product codes, first listed Oct 22, 2024
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | Class II | Cardiovascular | Contract manufacturing | Oct 22, 2024 |
| DQY | Catheter, Percutaneous | Class II | Cardiovascular | Contract manufacturing | Oct 22, 2024 |
| DYB | Introducer, Catheter | Class II | Cardiovascular | Contract manufacturing | Aug 29, 2025 |
| NRY | Catheter, Thrombus Retriever | Class II | Cardiovascular | Contract manufacturing | Oct 22, 2024 |
| QJP | Catheter, Percutaneous, Neurovasculature | Class II | Cardiovascular | Contract manufacturing | Oct 22, 2024 |