Manufacturer
bioMérieux
France, United StatesLegal entities : bioMérieux SA, bioMérieux, Inc.
Markets : Belgium · France · Germany · Greece · Italy · Netherlands · Poland · Spain · United States
Approvals : EU – class A, B, C · United States (FDA) – 510(k) : 284 · PMA : 3 · class I, II, III · latest in 2026 · see on the FDA website
Public contracts won : France 64 · Italy 33 · Spain 9 · Belgium 2 · Greece 2 · Poland 2 · Germany 1 · Netherlands 1
EU representative : bioMérieux SA (France)
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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