Manufacturer
Hangzhou Laihe Biotech
ChinaLegal entities : Hangzhou Laihe Biotech Co., Ltd.
Markets : Finland · France · Netherlands · Spain · United States
Approvals : EU – class B, C · United States (FDA) – 510(k) : 3 · class I, II · latest in 2025 · see on the FDA website
EU representative : SUNGO Europe B.V. (Netherlands)
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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