Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681822

FEI Number

3004547341

Entity Name

NOVO NORDISK A/S - NEEDLE MANUFACTURING AND SOURCI

City/State/Country

HJOERRING Nordjylland, DK

Establishment Address

STENAGER ALLE 4, HJOERRING Nordjylland --, DK

Establishment Type(s)

Manufacture Medical Device

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

K093109

PMA Number

N/A

All Registered Proprietary Names

NovoFine® Plus 32G 4 mm NovoFine® Plus NOVOFINE 32G Tip NovoFine® 30G NovoFine® 31G NovoFine® 32G NovoFine® Plus 32G x 4 mm (1/6") Disposable Needle NovoFine® Plus NovoFine® Plus NOVOFINE AUTOCOVER 30G NovoTwist 32G Tip NovoTwist 30G

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	2021-03-30
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-06-13
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	2014-05-30
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
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2010-06-23

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
9681821	NOVO NORDISK A/S	HILLEROED Hovedstaden, DK

Related 510(k) Records

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

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681822. Last updated year: 2026. Please use registration number 9681822 when referencing this establishment in official correspondence.