Contract manufacturerBIOMERICS FMI (Athens, TX)TexasCardiovascularGastroenterology and urologyEar, nose and throatClass IIUnclassifiedClass I
BIOMERICS FMI
Contract manufacturer · Athens, TX
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1646831 (openFDA record; or search FDA's registration database)
- FEI number
- 1000160215
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Biomerics FMI (FDA owner/operator no. 9008904)
- Registered address
- 1605/1704/1700 Enterprise St., Athens, TX 75751
- Contract listings
- 27 device listings, 15 product codes, first listed Jan 16, 2013
- 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 | Jan 16, 2013 |
| DQY | Catheter, Percutaneous | Class II | Cardiovascular | Contract manufacturing | Jan 16, 2013 |
| EYB | Catheter, Ureteral, Gastro-Urology | Class II | Gastroenterology and urology | Contract manufacturing | Jan 16, 2013 |
| EZN | Dilator, Catheter, Ureteral | Class II | Gastroenterology and urology | Contract manufacturing | Jan 16, 2013 |
| FAD | Stent, Ureteral | Class II | Gastroenterology and urology | Contract manufacturing | Jan 16, 2013 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Class II | Gastroenterology and urology | Contract manufacturing | Jan 16, 2013 |
| KOD | Catheter, Urological | Class II | Gastroenterology and urology | Contract manufacturing | Jan 16, 2013 |
| KOE | Dilator, Urethral | Class II | Gastroenterology and urology | Contract manufacturing | Dec 5, 2013 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Class II | Cardiovascular | Contract manufacturing | Jan 16, 2013 |
| LJE | Catheter, Nephrostomy | Unclassified | Gastroenterology and urology | Contract manufacturing | Jan 16, 2013 |
| LRC | Instrument, Ent Manual Surgical | Class I | Ear, nose and throat | Contract manufacturing | Apr 11, 2024 |
| OMZ | Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter | Class II | Cardiovascular | Contract manufacturing | Nov 21, 2014 |
| OZT | Balloon Aortic Valvuloplasty | Class II | Cardiovascular | Contract manufacturing | Dec 4, 2015 |
| PNO | Catheter, Percutaneous, Cutting/Scoring | Class II | Cardiovascular | Contract manufacturing | Sep 8, 2025 |
| PNZ | Eustachian Tube Balloon Dilation Device | Class II | Ear, nose and throat | Contract manufacturing | Apr 11, 2024 |