FDA Registration
Active
🇺🇸 United States
Biomerics NLE
Reg #: 3016079756
·
FEI: 3016079756
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Biomerics NLE
- Registration Number
- 3016079756
- FEI Number
- 3016079756
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 246 Main St
- City
- Monroe
- State
- CT
- ZIP
- 06468
- Country
- US
Owner / Operator
- Firm Name
- Biomerics
- Operator Number
- 10042380
- Address
- 6030 W Harold Gatty Drive
- City
- Salt Lake City
- State
- UT
- Postal Code
- 84116
- Country
- US
- Correspondent
- Jacob J Wakley
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2025-11-25 |
Proprietary Names
SP Obturator, Circular
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)