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 fulfils the requirements
of the international standard ISO 7550 and Vitrex
Micro hematocrit tubes fulfils the requirements
of the international standard ISO 12772.
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