Data / Medical devices / Belgium / Terumo Europe N.V.
Terumo Europe N.V.: FDA-registered device maker in LEUVEN Vlaams Brabant, Belgium, 23 510(k) clearances
Terumo Europe N.V. is registered with the FDA (registration 9681413) in LEUVEN Vlaams Brabant, Belgium. It lists 5 device types. The FDA files 23 510(k) clearances under its listings, the newest dated July 8, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9681413
- FEI number
- 3001570557
- Address
- Interleuvenlaan 40, LEUVEN Vlaams Brabant, Belgium, 3001
- Owner or operator
- Terumo Europe N.V. (10034088)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- November 4, 2010
- Registered through
- 2027
- Brand names listed
- 27G X 1/2, 27G x 1/2" TW K-Pack Surshield Needle, Hypodermic Needle for Single Use, K-Pack Embrace Active Safety Needle, K-Pack Enhance Needle, K-Pack II, K-Pack II 29G, K-Pack II Needle - 21G x 2 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Ophthalmic Needle | QYM | 2 | Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Exporter to the US | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| July 8, 2025 | K251447 | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) | FMI | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| May 29, 2025 | K243309 | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) | FMI | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| April 4, 2025 | K243581 | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) | FMI | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| October 18, 2023 | K230951 | Terumo Injection Filter Needle (NF-3013RBKE05M) | QYM | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| August 22, 2022 | K212095 | SurGuard3 Safety Hypodermic Needle | FMI | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| October 11, 2019 | K192057 | K-Pack II Needle - 27G x 1/2 Extra Thin Wall, K-Pack II Needle - 27G x 1/2 Ultra Thin Wall, K-Pack II Needle - 30G x 1/2 Extra Thin Wall, K-Pack II Needle - 30G x 1/2 Ultra Thin Wall | FMI | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| February 10, 2017 | K161606 | Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH | FMF | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| October 16, 2015 | K152362 | Terumo SurGuard 3 Safety Hypodermic Needle | FMI | Substantially Equivalent | Terumo (Philippines) Corporation | accessdata.fda.gov |
| June 25, 2015 | K151398 | K-Pack II Needle - 29G x 5/16 Thin Wall | FMI | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| April 1, 2015 | K150263 | K-Pack II Needle-21G x 2 | FMI | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| March 18, 2014 | K133894 | SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) | FPA | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| February 5, 2014 | K133867 | SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) | FPA | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| September 6, 2013 | K132233 | K-PACK II NEEDLE - 27G X 3/4 THIN WALL | FMI | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| August 28, 2012 | K122249 | TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE | FMI | Substantially Equivalent | Terumo (Philippines) Corporation | accessdata.fda.gov |
| March 5, 2012 | K113422 | TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE | FMI | Substantially Equivalent | Terumo (Philippines) Corporation | accessdata.fda.gov |
| September 22, 2011 | K111797 | 27 G X 1/2 K-PACK SURSHIELD NEEDLE | FMI | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| June 9, 2011 | K110850 | K-PACK II NEEDLE- 27G & 30G THIN WALL | FMI | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| June 6, 2011 | K110527 | K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE | FMI | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| October 23, 2008 | K082820 | K-PACK II NEEDLE - 29G THIN WALL | FMI | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| September 15, 2006 | K062608 | 29G AND 30G K-PACK II NEEDLE | FMI | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| September 27, 2005 | K051865 | TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR | MEG | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| December 18, 2002 | K023271 | TERUMO SYRINGE WITH/WITHOUT NEEDLE | FMF | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| June 14, 1999 | K984576 | K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE (HYPODERMIC NEEDLE) 25G X 1, MODEL KN-2525RB, K | FMI | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Piston
- All makers of Set, Administration, Intravascular
- All makers of Syringe, Antistick
- All makers of Ophthalmic Needle
Updated July 8, 2025. 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.