FDA Registration
Active
🇺🇸 United States
NOVO NORDISK INC.
Reg #: 2244771
·
FEI: 2244771
·
Expires 2026
Products
4
Proprietary Names
14
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- NOVO NORDISK INC.
- Registration Number
- 2244771
- FEI Number
- 2244771
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 800 Scudders Mill Rd
- City
- Plainsboro
- State
- NJ
- ZIP
- 08536
- Country
- US
Regulatory Submissions
- 510(k) Number
- K182387
Owner / Operator
- Firm Name
- NOVO NORDISK INC.
- Operator Number
- 9027307
- Address
- 800 Scudders Mill Road
- City
- Plainsboro
- State
- NJ
- Postal Code
- 08536
- Country
- US
- Correspondent
- Rinku Sur
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2019-01-22 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2014-05-30 |
| Introducer, Syringe Needle | KZH | Class 2 | General Hospital | No | 2015-07-15 |
| I.V. Start Kit | LRS | Class 2 | General Hospital | No | 2007-11-29 |
Proprietary Names
NovoPen Echo
NovoFine® Plus 32G x 4 mm (1/6") Disposable Needle
NovoFine® Plus
NovoFine 32G Tip
NovoFine® Plus 32G 4 mm
NovoFine® 30G
NovoFine® 31G
NovoFine® 32G
NOVOFINE AUTOCOVER 30G
FLEXPRO PENMATE
NovoTwist 32G Tip
NovoTwist 30G
NOVOFINE 32G Tip
Administration Set
Establishment Types
Complaint File Establishment per 21 CFR 820.198