Certificates

For more than 40 years, Barkey and its experienced employees have been developing, producing and selling devices and systems for medical and laboratory technology. We attach great importance to customer proximity and sustainable satisfaction.

In addition, our QM system is based on the Canadian Medical Device Regulations (CMDR) and Quality System Regulation (QSR) CFR 21 Part 820 of the US Food and Drug Administration (FDA) and the national requirements of the individual countries to which our devices are exported.

Barkey is certified according to DIN EN ISO 13485.

MDR Certificate EN


Download Certificate
EG Zertifikat EN


Download Certificate
EG Zertifikat DE


Download Certificate
QM Zertifikat ISO 13485 EN


Download Certificate
QM Zertifikat ISO 13485 DE


Download Certificate
plasmatherm FDA EN


Download Certificate