Hemedis products are supplied by reliable partners with long-term experience in medical device production. The high-quality products of our main supplier, Hegewald Medizinprodukte GmbH, are exclusively manufactured under clean-room conditions (class 8, EN 14644-1) to ensure consistent quality, production processes are continuously controlled and monitored according to the requirements of Council directive 93/42/EEC, and relevant product specific guidelines. Hegewald is certified according to DIN EN ISO 13485:2003, and also maintains Annex II- and V-certificates for the manufacturing and distribution of sterile medical device products. Hegewald declares conformity according to Council directive 93/42/EEC for all products supplied to Hemedis.
The final products are sterilized in a validated process and can be used immediately. We attach great importance to the reliability of our partners to meet all customer requirements and quality criteria.
All MiXi-products are produced by Hegewald Medinzinprodukte GmbH.