FDA Registration
Active
🇺🇸 United States
NOVAERUS US INC.
Reg #: 3019543795
·
FEI: 3019543795
·
Expires 2026
Products
1
Proprietary Names
10
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NOVAERUS US INC.
- Registration Number
- 3019543795
- FEI Number
- 3019543795
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3540 Toringdon Way Ste 200
- City
- Charlotte
- State
- NC
- ZIP
- 28277
- Country
- US
Regulatory Submissions
- 510(k) Number
- K200321
Owner / Operator
- Firm Name
- Novaerus US Inc.
- Operator Number
- 10082124
- Address
- 3540 Toringdon Way, Suite 200
- City
- Charlotte
- State
- NC
- Postal Code
- 28277
- Country
- US
- Correspondent
- Lisa Lawlor
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cleaner, Air, Medical Recirculating | FRF | Class 2 | General Hospital | No | 2021-06-17 |
Proprietary Names
Novaerus Defend 400
Novaerus Defend 1050
WellAir Pro XL
Novaerus Pro XL
WellAir NV400
WellAir NV1050
Novaerus NV400
WellAir Defend 1050
Novaerus NV1050
WellAir Defend 400
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility