FDA Registration Active 🇩🇰 Denmark

NOVO NORDISK A/S

Reg #: 9681821 · FEI: 3003131673 · Expires 2026
Products
4
Proprietary Names
14
Establishment Types
2
Classifications
4

Registration Details

Registration Name
NOVO NORDISK A/S
Registration Number
9681821
FEI Number
3003131673
Status
Active
Expiry Year
2026
Initial Importer
No
Address
BRENNUM PARK
City
HILLEROED Hovedstaden
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
Rinku Sur

US Agent

Business Name
NOVO NORDISK INC.
Contact Name
Prabhdeep Singh
Address
800 Scudders Mill Rd
City
Plainsboro
State
NJ
ZIP
08536
Country
US
Phone
609 9875439

Products

Device Name Product Code
Needle, Hypodermic, Single Lumen FMI
Syringe, Piston FMF
I.V. Start Kit LRS
Introducer, Syringe Needle KZH

Proprietary Names

NovoFine® Plus 32G x 4 mm (1/6") Disposable Needle NovoFine® Plus NovoFine® 30G NovoFine® 31G NovoFine® 32G NovoFine 32G Tip NovoTwist 32G Tip NovoTwist 30G NOVOFINE AUTOCOVER 30G NOVOFINE 32G Tip NovoPen Echo Administration Set FLEXPRO PENMATE NovoFine® Plus 32G 4 mm

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device