Contract manufacturerLake Region Medical (Trenton, GA)GeorgiaCardiovascularClass IIClass III
Lake Region Medical
Contract manufacturer · Trenton, GA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3004063494 (openFDA record; or search FDA's registration database)
- FEI number
- 3004063494
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Lake Region Medical (FDA owner/operator no. 9048369)
- Registered address
- 13024 NORTH MAIN ST., Trenton, GA 30752
- Contract listings
- 2 device listings, 3 product codes, first listed Oct 29, 2014
- 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 |
|---|---|---|---|---|---|
| DQY | Catheter, Percutaneous | Class II | Cardiovascular | Contract manufacturing | Feb 21, 2025 |
| OAE | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | Class III | Cardiovascular | Contract manufacturing | Oct 29, 2014 |
| QJP | Catheter, Percutaneous, Neurovasculature | Class II | Cardiovascular | Contract manufacturing | Feb 21, 2025 |