Data / Medical devices / Denmark / Novo Nordisk A/S - Needle Manufacturing And Sourci
Novo Nordisk A/S - Needle Manufacturing And Sourci: FDA-registered device maker in HJOERRING Nordjylland, Denmark, 8 510(k) clearances
Novo Nordisk A/S - Needle Manufacturing And Sourci is registered with the FDA (registration 9681822) in HJOERRING Nordjylland, Denmark. It lists 1 device type. The FDA files 8 510(k) clearances under its listings, the newest dated August 25, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9681822
- FEI number
- 3004547341
- Address
- Stenager Alle 4, HJOERRING Nordjylland, Denmark, --
- Owner or operator
- NOVO NORDISK INC. (9027307)
- Roles
- Manufacturer
- First device listed
- November 27, 2006
- Registered through
- 2026
- Brand names listed
- NOVOFINE 32G Tip, NOVOFINE AUTOCOVER 30G, NovoFine 32G Tip, NovoFine® 30G, NovoFine® 31G, NovoFine® 32G, NovoFine® Plus, NovoFine® Plus 32G 4 mm and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| August 25, 2023 | K231255 | NovoFine® Plus | FMI | Substantially Equivalent | Novo Nordisk, Inc. | accessdata.fda.gov |
| 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 |
| 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
Updated August 25, 2023. 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.