Certificate

The buyers can be assured that they receive carefully selected and quality assured products. All products sold by bioactiva diagnostica GmbH are CE-certified and our quality management system meets all requirements of the EN ISO 13485 standard. Our portfolio includes more than 2,000 different products. To explore a comprehensive list of them, you can search our online store or contact us directly.

EN ISO 13485 Standard. Quality Management System.

Bioactiva diagnostica GmbH is certified for the development, manufacturing and distribution of in-vitro diagnostics using molecular biology and immunological methods and selective media for detection of pathogens; distribution of medical devices in the field of blood pressure measuring, medical equipment and instruments including otoscopes, ophthalmoscopes, dermatoscopes, laryngoscopes, stethoscopes, ventilators, endoscopy, reflex and precision hammers and tuning forks as well as patient monitoring systems in the field of anaesthesia, ECG, pulse oximetry and fetal monitoring, portable x-ray devices, scales, dental chair units and other examination devices with corresponding accessories.
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EC Certificate. Quality System for the design, manufacture and final inspection.

Bioactiva diagnostica GmbH is EC Certified for the scope: ELISA-test kits for the determination of Toxoplasma, Rubella, CMV, Chlamydia. The mdc audit has proven that the quality system meets all requirements according to ANNEX IV - excluding Section 4 and 6 of the Council Directive 98/79/EC of the European Parliament and the Council of 27 October 1998 on the in vitro diagnostic medical devices.
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