FDA Registration
Active
🇺🇸 United States
iLumin
Reg #: 3005641545
·
FEI: 3005641545
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NOVA EYE INC.
- Registration Number
- 3005641545
- FEI Number
- 3005641545
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 41316 Christy St
- City
- Fremont
- State
- CA
- ZIP
- 94538
- Country
- US
Regulatory Submissions
- 510(k) Number
- K062259
Owner / Operator
- Firm Name
- Nova Eye Medical Ltd
- Operator Number
- 10075633
- Address
- 107 Rundle Street
- City
- Kent Town
- State
- South Australia
- Postal Code
- 5067
- Country
- AU
- Correspondent
- Don Watton
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoilluminator | MPA | Class 2 | Gastroenterology, Urology | No | 2020-06-22 |
Proprietary Names
iLumin
Establishment Types
Manufacture Medical Device