Manufacturer
PENTAX Medical
JapanLegal entities : PENTAX Medical Corporation
Markets : Belgium · Germany · Spain · United States
Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 20 · class II · latest in 2019 · see on the FDA website
Public contracts won : Spain 3 · Belgium 1
EU representative : PENTAX Europe GmbH (Germany)
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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