FDA Registration
Active
🇺🇸 United States
BIOMERICS FMI
Reg #: 1646831
·
FEI: 1000160215
·
Expires 2026
Products
15
Proprietary Names
11
Establishment Types
1
Classifications
15
Registration Details
- Registration Name
- BIOMERICS FMI
- Registration Number
- 1646831
- FEI Number
- 1000160215
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1605/1704/1700 Enterprise St.
- City
- Athens
- State
- TX
- ZIP
- 75751
- Country
- US
Owner / Operator
- Firm Name
- Biomerics FMI
- Operator Number
- 9008904
- Address
- 1605/1704/1700 ENTERPRISE ST., --
- City
- Athens
- State
- TX
- Postal Code
- 75751
- Country
- US
- Correspondent
- STACEY - LYONS
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2013-01-16 |
| Catheter, Nephrostomy | LJE | Class U | Unknown | No | 2013-01-16 |
| Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter | OMZ | Class 2 | Cardiovascular | No | 2014-11-21 |
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2013-01-16 |
| Dilator, Catheter, Ureteral | EZN | Class 2 | Gastroenterology, Urology | No | 2020-06-10 |
| Dilator, Urethral | KOE | Class 2 | Gastroenterology, Urology | No | 2020-06-10 |
| Catheter, Ureteral, Gastro-Urology | EYB | Class 2 | Gastroenterology, Urology | No | 2013-01-16 |
| Stent, Ureteral | FAD | Class 2 | Gastroenterology, Urology | No | 2013-01-16 |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | Class 2 | Cardiovascular | No | 2013-01-16 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2013-01-16 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2024-04-11 |
| Eustachian Tube Balloon Dilation Device | PNZ | Class 2 | Ear, Nose, Throat | No | 2024-04-11 |
| Balloon Aortic Valvuloplasty | OZT | Class 2 | Cardiovascular | No | 2022-05-10 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2013-01-16 |
| Catheter, Percutaneous, Cutting/Scoring | PNO | Class 2 | Cardiovascular | No | 2025-09-08 |
Proprietary Names
Vida PTV Dilatation Catheter
Access Sheath
Vensure Balloon dilation system
catheter, angioplasty, peripheral, transluminal
Cascade ureteral stent
Proxis Ureteral Access Sheath
Atlas Gold PTA Dilation Catheter
Dual Lumen Catheter
Renal Sheath
Catheter, angioplasty, peripheral, transluminal
Cageant
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)