Since October 22nd, 2018 the HCS HealthCare Supply GmbH, Aachen is certified according to Annex II.3 of the Medical Device Directive 93/42/EEC
for its complete quality management. Additional certificates are issued for the fulfilment of the DIN EN ISO 13485. The certificates issued
by the Notified Body TÜV NORD Cert GmbH, Essen, CE 0044 are valid until May 26
th, 2024.

With the coming into force of the Medical Device Regulation MDR (EU) 2017/745 at May 26th, 2021 all relevant requirements of this regulation and of the new German medical device law (Deutsches Medizinprodukterecht-Durchführungsgesetz MPDG) are fulfilled.