Compliances

PPE EU Regulation 2016/425 CE Category III

PPE EU Regulation 2016/425 CE Category III

Medical Device Authority

LGM License

LGM License

LGM License

EU Declaration of Conformity

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

Medical Device Regulations (EU) 2017/745 CE Class I

Medical Device Regulations (EU) 2017/745 CE Class I

EU Declaration of Conformity & Instruction for Use (In Greek)

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