FDA Registration
Active
🇩🇰 Denmark
NovoFine® Plus
Reg #: 9681822
·
FEI: 3004547341
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NOVO NORDISK A/S - NEEDLE MANUFACTURING AND SOURCI
- Registration Number
- 9681822
- FEI Number
- 3004547341
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- STENAGER ALLE 4
- City
- HJOERRING Nordjylland
- Country
- DK
Regulatory Submissions
- 510(k) Number
- K133738
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
- Prabhdeep Singh
US Agent
- Business Name
- NOVO NORDISK INC.
- Contact Name
- Prabhdeep Singh
- Address
- 800 Scudders Mill Rd
- City
- Plainsboro
- State
- NJ
- ZIP
- 08536
- Country
- US
- [email protected]
- Phone
- 609 9875439
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2014-05-30 |
Proprietary Names
NovoFine® Plus
NovoFine® Plus 32G x 4 mm (1/6") Disposable Needle
Establishment Types
Manufacture Medical Device