Manufacturer
Terumo
China, JapanLegal entities : TERUMO Medical Products(Hangzhou) Co.,Ltd.,, Terumo Corporation
Markets : Belgium · France · Germany · Ireland · Italy · Poland · Portugal · Spain · United States
Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 260 · PMA : 3 · class I, II, III · latest in 2026 · see on the FDA website
Public contracts won : France 366 · Spain 111 · Portugal 54 · Italy 7 · Belgium 6 · Poland 3 · Germany 2 · Ireland 2
EU representative : TERUMO EUROPE N.V. (Belgium)
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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