FDA Registration
Active
🇺🇸 United States
NOVIDAN, INC.
Reg #: 3015651976
·
FEI: 3015651976
·
Expires 2026
Products
4
Proprietary Names
16
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- NOVIDAN, INC.
- Registration Number
- 3015651976
- FEI Number
- 3015651976
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 678 Mendelssohn Ave N
- City
- Golden Valley
- State
- MN
- ZIP
- 55427
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223848
Owner / Operator
- Firm Name
- Novidan, Inc.
- Operator Number
- 10061834
- Address
- 678 Mendelssohn Ave N
- City
- Golden Valley
- State
- MN
- Postal Code
- 55427
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Self-Fitting Air-Conduction Hearing Aid, Over The Counter | QUH | Class 2 | Ear, Nose, Throat | No | 2025-03-03 |
| Self-Fitting Air-Conduction Hearing Aid, Prescription | QDD | Class 2 | Ear, Nose, Throat | No | 2021-05-12 |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2023-07-25 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | Class 2 | Ear, Nose, Throat | No | 2022-12-02 |
Proprietary Names
NoviMed Pro
NoviMed BTE
Sonify Hearing Mach I
Sonify Hearing Mach I Pro
Sonify Hearing Mach II Pro
NoviOne RIC R
NoviOne RIC
NoviMed Hearing Pro R
NoviOne BTE
NoviOne RIC Wireless
NoviOne RIC W R
NoviOne RIC Wireless LG
NoviMed Pro Wireless
Sonify Hearing Mach II Pro W
Sonify Hearing Mach I Pro W
NoviMed Hearing Pro W R
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198