Quality and certifications

ISO 9001 and ISO 13485 certified. Product documentation is held for the categories that require it.

ISO 9001, SGS REACH and ISO 13485 certificates (reference copies)
ISO 9001 certificate (reference copy)

ISO 9001:2015

Quality management system. Valid until May 2029.

ISO 13485 certificate (reference copy)

ISO 13485:2016

Quality management system for medical devices (in vitro diagnostic reagents). Valid until May 2029.

EC Declaration of Conformity – Urinalysis Reagent Strips (reference copy)

CE – Urinalysis reagent strips

EC Declaration of Conformity under IVDD 98/79/EC.

EC Declaration of Conformity – One Step Multi-Drug Screen (reference copy)

CE – Multi-drug screen tests

EC Declaration of Conformity under IVDD 98/79/EC.

EU Authorized Representative certificate of notification (reference copy)

EU Authorized Representative

Notification of the CE-marked devices, registered in Spain through our EU representative.

SGS REACH SVHC test report for water test strips (reference copy)

REACH (SVHC) test report

SGS test of water test strips against the ECHA candidate list: 250 substances, pass.

Copies shown here are for reference. Certificate numbers and signatures are hidden; we send full documents on request. Import and registration rules vary by country. Please check the requirements for your market before ordering.

Request full documents