QA

VITREX MEDICAL A/S has a well-established quality system meeting the requirements of the international quality standards ISO 9001 and ISO 13485 and certified by BVQI Denmark A/S

VITREX MEDICAL is an FDA registered establishment.

The capillary tubes are CE marked and in conformity with the essential requirements and procedures of the European Council Directive 98/79/EC on in-vitro diagnostic medical devices.

The blood lancets are CE marked and in conformity with the essential requirements and procedures of the European Council Directive 93/42/EC on medical devices.

VITREX Medical A/S has been assessed by and is under the supervision of G-Med, Notified Body No. 0459

VITREX End-to-End Micro pipettes and pre-calibrated pipettes fulfills the requirements of the international standard ISO 7550 and VITREX Micro hematocrit tubes fulfills the requirements of the international standard ISO 12772.