Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2244771

FEI Number

2244771

Entity Name

NOVO NORDISK INC.

City/State/Country

Plainsboro, NJ, US

Establishment Address

800 Scudders Mill Rd, Plainsboro, NJ 08536, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

NOVO NORDISK INC. (Owner Number: 9027307)

Owner / Operator Contact Address

800 Scudders Mill Road, Plainsboro, NJ 08536, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K050106

PMA Number

N/A

All Registered 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® Plus NovoFine® 30G NovoFine® 31G NovoFine® 32G NovoFine® Plus NOVOFINE AUTOCOVER 30G

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2019-01-22
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2014-05-30
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2018-12-06
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-03-30
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-12-10
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-09-12
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2006-11-27

Official Correspondent

Rinku Sur

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NOVO NORDISK INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005186124	Novo Nordisk (China) Pharmaceuticals, Co. Ltd.	Tianjin, CN
3002807751	NOVO NORDISK A/S	Kalundborg Sjalland, DK
9681821	NOVO NORDISK A/S	HILLEROED Hovedstaden, DK
9681822	NOVO NORDISK A/S - NEEDLE MANUFACTURING AND SOURCI	HJOERRING Nordjylland, DK

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

Registration Number	Establishment Name	Location
3027338968	RONCADELLE OPERATIONS SRL	Castel Mella Brescia, IT
3029328631	PEGASUS IMPORTS	Houston, TX, US
3021067373	VVT MED Ltd	Kfar Saba Central, IL
3009249481	JMS Co.,Ltd. Miyoshi Plant	Miyoshi Hiroshima, JP
1416980	BAXTER HEALTHCARE CORPORATION	ROUND LAKE, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2244771. Last updated year: 2026. Please use registration number 2244771 when referencing this establishment in official correspondence.