Our CE – marked products fulfil the EU – directive 98/79/EG,
and they are registered and approved by the state office in charge.
View here our EC-Certificate for RealLine CMV quantitative, RealLine Rubella and RealLine Chlamydia Kits.
EC Certificate EN
EC Certificate DE
BIORON Diagnostics GmbH is also certified according to the European standard DIN EN ISO 13485:2016. Below you can view our current certificate.
ISO 13485:2016 Certificate EN
ISO 13485:2016 Certificate DE
ISO 13485:2016 Certificate ES
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