Manufacturer
Hangzhou Genesis Biodetection Biocontrol
ChinaLegal entities : Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Markets : Belgium · Cyprus · Greece · Netherlands · Spain · United States
Approvals : EU – class A · United States (FDA) – 510(k) : 1 · class I, II · latest in 2023 · see on the FDA website
EU representative : CMC Medical Devices & Drugs SL (Spain)
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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