Testing of the product characteristics

The National Accreditation Agency of Ukraine confirmed the technical competence of the UNI-CERT Testing Laboratory against DSTU ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories (ISO/IEC 17025:2017, IDT) with an Accreditation certificate No. 201394 dated 20 April 2021).

The laboratory’s scope of activities covers the testing of the following products:

  • medical devices, namely medical gauze, gauze roller bandages, elastic medical bandages, gauze pads and gauze cuts, disposable medical gloves, single-use syringes, sterile single-use injection needles;
  • in vitro diagnostic devices, namely single-use receptacles for the collection of specimens, other than blood, from humans, single-use containers for human venous blood specimen collection, single use intravascular sterile catheters, and the information compliance on the labels applied by the manufacturer;
  • active implantable medical devices as related the information compliance on the labels applied by the manufacturer;
  • personal protective equipment, namely masks, half masks and quarter masks;
  • anti-aerosol filters, threaded connections for face pieces, filter half masks for protection against aerosols, filter half masks with valves to protect against gases or gases and aerosols, half masks without inhalation valves and with separable filters to protect against gases or gases and aerosols, or only from aerosols , filters with breathing hoses (non-mask filters): aerosol, gas mask and combined, gas and combined filters;
  • safe shoes;
  • protective clothing, protective gloves;
  • surgical masks;
  • nipple rubber and latex babies;
  • walking aids operated with one hand;
  • rubber condoms;
  • sets and clothing for protection from the cold;
  • protective clothing against infectious agents;
  • protective clothing against chemicals;
  • textile materials.

Select test types

We will be glad to answer your questions. You can contact us via the contact page

Other services

Conformity assessment of personal protective equipment

Read more

Quality Management System Certification

The presence of a certified Quality Management System (QMS) provides the company with a number of advantages: The efficiency and effectiveness of processes are optimized and increased; The quality of products and/or services improves; The company becomes one that independently improves and develops, requires less attention from the company’s management; The effectiveness of decision-making increases; […]

Read more

Conformity assessment of medical devices

Since 1 July 2015, it has been a mandatory requirement that medical devices, before being placed on the Ukrainian market and/or put into service, must be subject to the assessment of conformity with the Technical regulations (TR) (approved by Resolutions No. 753, 754, 755 of the CMU of 2 October 2013). Clause 21 of Resolution No. […]

Read more

Ask your question

Or find the answer here

*All fields are required