Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681821

FEI Number

3003131673

Entity Name

NOVO NORDISK A/S

City/State/Country

HILLEROED Hovedstaden, DK

Establishment Address

BRENNUM PARK, HILLEROED Hovedstaden DK-3400, DK

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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	2021-12-10
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	2010-06-23
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2006-11-27
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-06-13
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2019-01-22
LRS	I.V. Start Kit	General Hospital	Class 2	880.5200	2007-11-29

Official Correspondent

Rinku Sur

US Agent Details

Prabhdeep Singh Business: NOVO NORDISK INC. Email: prsi@novonordisk.com Phone: (609) 9875439

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
2244771	NOVO NORDISK INC.	Plainsboro, NJ, US
9681822	NOVO NORDISK A/S - NEEDLE MANUFACTURING AND SOURCI	HJOERRING Nordjylland, DK

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681821. Last updated year: 2026. Please use registration number 9681821 when referencing this establishment in official correspondence.