PPE EU Regulation 2016/425 CE Category III
Medical Device Authority
LGM License
EU Declaration of Conformity
ISO 9001:2015
ISO 13485:2016 (Medical Device)
ISO 13485:2016 (Standard Malaysia)
Medical Device Regulations (EU) 2017/745 CE Class I
EU Declaration of Conformity & Instruction for Use (In Greek)
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