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Certified Management Systems
Management Systems
EN ISO 13485 and ISO 9001
Certificate Holder
GENSPEED Biotech GmbH
Test Mark Number
0000058115
The certificate holder's Management System corresponds to standards:
EN ISO 13485:2016
ISO 9001:2015
Certificate scopes
EN ISO 13485
Design and development, manufacture and distribution of molecular diagnostic test kits and instruments for the detection of nosocomial infections, periodontitis and peri-implantitis.
Design and development of immunoassays for the detection and/ or quantification of infectious diseases and inflammatory markers.
Installation and service of instruments.
ISO 9001
Design and development, manufacture and distribution of test kits and analysis instruments (including installation and service) for detection of various analytes in sample material.
