Manufacturer
Ortho-Clinical Diagnostics
United Kingdom (ex Northern Ireland)
Markets : Belgium · France · Germany · Italy · United States
Approvals : EU – class A, C · United States (FDA) – 510(k) : 147 · PMA : 8 · class I, II, III · latest in 2026 · see on the FDA website
Public contracts won : France 77 · Italy 8 · Belgium 1 · Germany 1
EU representative : Ortho-Clinical Diagnostics France (France)
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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