TERUMO EUROPE N.V.
BE-MF-000001434 · Belgium · Leuven
TERUMO EUROPE N.V. is registered in the European database on medical devices as a manufacturer, with 243 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 142 |
|---|---|
| Class IIa | 101 |
Among these devices, 243 are declared sterile, 142 implantable, 7 with a measuring function.
Devices declared under this manufacturer
- K-Pack Enhance Needle
- K-Pack Surshield Needle
- Neolus Needle
- RADIFOCUS Guide Wire M Non-Vascular
- RADIFOCUS Introducer II
- SurGuard3 Safety Hypodermic Needle
- Surflo Winged Infusion Set with Filter and Needle Protection (Surshiel
- Surflo Winged Infusion Set with Needle Protection (Surshield)
- TERUMO SYRINGE with Fixed Needle For use only with GONAL-F Multi-Dose
- TERUMO SYRINGE with Fixed Needle GONAL-f Multi-Dose 1050 IU/1.75 ml 45
- TERUMO SYRINGE with Fixed Needle Menopur Multidose 600 IU/ml FSH/LH
- Terumo Injection Filter Needle
Showing 12 of 243 declared devices.
Catalogue references include DE-RQ2518KSM, DE-RQ2715KSM, DE-RS2524ASM, DE-RS2533ASM, DE-RS3515ASM, DE-RS4528ASM.
European nomenclature codes declared: P070402010301, G0399,U0601, A0101010102, A01010201, A0101010101, C0504.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | TERUMO EUROPE N.V. (BE) · FDA 9681413 |
| Devices in EUDAMED | 243 |
| Country of registration | Belgium |
Device-level evidence
| Devices with a numeric GTIN | 243 |
|---|---|
| Found in the U.S. device database | 20 |
| Share | 8.2 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | TERUMO EUROPE N.V. |
What it holds in Canada
| Licences on record | 7 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 7 |
| First licensed | 2006-05-30 |
Licence types: Device Family (3), Single Device (3), Device Group Family (1).
Licensed under: HYPODERMIC NEEDLES, SURFLO WINGED INFUSION SET WITH NEEDLE PROTECT, SURFLO WINGED INFUSION SET WITH FILTER AND NEE, K-PACK SURSHIELD NEEDLE, TERUMO INJECTION FILTER NEEDLE, K-PACK EMBRACE ACTIVE SAFETY NEEDLE.
North American profile: Both markets. TERUMO EUROPE N.V. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1594584-1 | supplemented | 2026-12-31 |
3479GB448221124 | issued | 2026-11-30 |
20232GB450221124 | issued | 2026-11-30 |
13090GB450250128 | issued | 2030-01-27 |