Manufacturer
SSI Diagnostica
DenmarkLegal entities : SSI Diagnostica A/S
Markets : Denmark · Northern Ireland · Norway · Spain · Sweden · United States
Approvals : EU – class A · United States (FDA) – 510(k) : 1 · class I, II · latest in 2020 · see on the FDA website
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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