Data / Medical devices / Denmark / Novo Nordisk A/S
Novo Nordisk A/S: FDA-registered device maker in HILLEROED Hovedstaden, Denmark, 8 510(k) clearances
Novo Nordisk A/S is registered with the FDA (registration 9681821) in HILLEROED Hovedstaden, Denmark. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated June 23, 2021. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 9681821
- FEI number
- 3003131673
- Address
- Brennum Park, HILLEROED Hovedstaden, Denmark, DK-3400
- Owner or operator
- NOVO NORDISK INC. (9027307)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- November 27, 2006
- Registered through
- 2026
- Brand names listed
- Administration Set, FLEXPRO PENMATE, NOVOFINE 32G Tip, NOVOFINE AUTOCOVER 30G, NovoFine 32G Tip, NovoFine® 30G, NovoFine® 31G, NovoFine® 32G and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| I.V. Start Kit | LRS | 2 | Specification developer | accessdata.fda.gov |
| Introducer, Syringe Needle | KZH | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 23, 2021 | K210258 | NovoFine | FMI | Substantially Equivalent | Novo Nordisk, Inc. | accessdata.fda.gov |
| December 19, 2020 | K202005 | NovoFine Plus 32G Tip x 4 mm | FMI | Substantially Equivalent | Novo Nordisk, Inc. | accessdata.fda.gov |
| December 17, 2018 | K182387 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | FMF | Substantially Equivalent | Novo Nordisk, Inc. | accessdata.fda.gov |
| January 17, 2018 | K173479 | NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) | FMI | Substantially Equivalent | Novo Nordisk, Inc. | accessdata.fda.gov |
| May 21, 2014 | K133738 | NOVOFINE PLUS 32G 4 MM | FMI | Substantially Equivalent | Novo Nordisk, Inc. | accessdata.fda.gov |
| June 18, 2010 | K093109 | NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5') | FMI | Substantially Equivalent | Novo Nordisk, Inc. | accessdata.fda.gov |
| February 1, 2010 | K090111 | FLEXPEN NEEDLE | FMI | Substantially Equivalent | Novo Nordisk, Inc. | accessdata.fda.gov |
| March 30, 2005 | K050106 | NOVOFINE AUTOCOVER 30G X 8MM | FMI | Substantially Equivalent | Novo Nordisk, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Piston
- All makers of I.V. Start Kit
- All makers of Introducer, Syringe Needle
Updated June 23, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.