FDA Registration
Active
🇺🇸 United States
NANOENTEK AMERICA, INC
Reg #: 3007113174
·
FEI: 3007113174
·
Expires 2026
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NANOENTEK AMERICA, INC
- Registration Number
- 3007113174
- FEI Number
- 3007113174
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 220 Bear Hill Road Suite 102
- City
- North Waltham
- State
- MA
- ZIP
- 02451
- Country
- US
Owner / Operator
- Firm Name
- NanoEntek, Inc
- Operator Number
- 10041714
- Address
- 220 Bear Hill Road Suite 102
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
- Correspondent
- Jacob Jung
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fluorometer, For Clinical Use | KHO | Class 1 | Clinical Chemistry | No | 2025-12-15 |
Proprietary Names
F10
FREND System
FREND 2
Establishment Types
Complaint File Establishment per 21 CFR 820.198