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Sign in to claim this brandNOVO NORDISK INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 800 Scudders Mill Rd, Plainsboro, NJ, 08536
- Website
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- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 2244771
- DUNS Number
- —
Catalogue (29)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NovoFine® 32G Tip | 185197 | FDA UDI | Class II | Active |
| NovoFine® 30G | 185250 | FDA UDI | Class I | Unknown |
| FlexPro® PenMate® | 771290 | FDA UDI | Class II | Active |
| Administration Set | 720006 | FDA UDI | Class II | Active |
| NovoFine® 32G Tip | 185189 | FDA UDI | Class II | Active |
| NovoFine® Autocover® 30G | 185275 | FDA UDI | Class II | Active |
| NovoFine® Plus 32G | 185591 | FDA UDI | Class II | Active |
| NovoFine® Plus 32G | 185650 | FDA UDI | Class II | Active |
| NovoFine® Plus 32G | 185651 | FDA UDI | Class II | Unknown |
| NovoTwist® 32G | 185389 | FDA UDI | Class II | Active |
| NovoFine® Autocover® 30G | 185297 | FDA UDI | Class II | Active |
| NovoFine® Plus 32G | 185851 | FDA UDI | Class II | Active |
| NovoFine® Plus 32G | 185850 | FDA UDI | Class II | Active |
| NovoPen Echo® | 185459 | FDA UDI | Class II | Active |
| NovoFine® Plus 32G | 185550 | FDA UDI | Class II | Active |
| NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | K150874 | FDA 510(k) | Class II | Active |
| NovoFine | K210258 | FDA 510(k) | Class II | Active |
| Novofine Plus 32g 4 Mm | K133738 | FDA 510(k) | Class II | Active |
| Novofine 32g Tip | K053470 | FDA 510(k) | Class II | Active |
| NovoFine Plus 32G Tip x 4 mm | K202005 | FDA 510(k) | Class II | Active |
| Novotwist Needle, Models 30g * 8mm (1/3) 32 G Tip * 5 Mm(1/5') | K093109 | FDA 510(k) | Class II | Active |
| NovoPen Echo | K162602 | FDA 510(k) | Class II | Active |
| NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | K182387 | FDA 510(k) | Class II | Active |
| Flexpen Needle | K090111 | FDA 510(k) | Class II | Active |
| NovoFine® Plus | K231255 | FDA 510(k) | Class II | Active |
| Novofine Autocover 30g X 8mm | K050106 | FDA 510(k) | Class II | Active |
| Novopen Echo, A Dial A Dose Insulin Delivery Pen | K123766 | FDA 510(k) | Class II | Active |
| Flexpen Needle | K062500 | FDA 510(k) | Class II | Active |
| NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) | K173479 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 5, 2017 | Z-0206-2018 | — | terminated | A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents. |