COMPANY

Dunavplast is a leading company in the production and trade of medical devices in the territory of the Republic of Serbia. Dunavplast has been founded in 1982. and it is a complete family-owned business.

The majority of users of these products are laboratories, health centers, hospitals, clinical centers, institutes, institutes, as well as pharmacies and pharmaceutical, food, chemicals industry and many others.

Many years of experience have established a quality policy that is aimed at providing products to all interested clients/customers at competitive prices while respecting high standards in terms of quality and delivery speed.

The business is carried out in accordance with the guidelines of good manufacturing practice, as well as all positive regulations of the Republic of Serbia. Also, the business is in line with ISO standards, which establishes an integrated management system:

  • ISO 9001: 2015 (SRPS ISO 9001: 2015) – Quality management system,
  • ISO 13485: 2016 (SRPS ISO 13485: 2016) – Quality management system for the development and production of medical devices,
  • ISO 14001: 2015 (SRPS ISO 14001: 2005) – Environmental protection system,
  • OHSAS 18001: 2007 (SRPS OHSAS 18001: 2008) – Occupational Health and Safety Management System.

All of the products are CE marked.

The certification was performed by the well known certification german company DQS, which is member of largest sertification network IQNet.

DUNAVPLAST is focused on continuous modernization of equipment, expanding product range and increasing customer satisfaction.

First part, most of the production program, has been classified by the Agency for Medicines and Medical Devices of Serbia in 4 classes:

  • Class I (category 05 – hospital, apparatus equipment, category 10 – disposable medical devices, category 11 – technical facilities for handicapped persons),
  • Class Is (Category 10 – Disposable medical devices),
  • Class Im (category 10 – disposable medical devices),
  • Class the rest (category 06 – “In vitro” diagnostic medical devices).

 

In addition to registration in the Agency for Medicines and Medical Devices of Serbia, the products are registered in the Agency for Medicines and Medical Devices of Montenegro and the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina.

The second part of the DUNAVPLAST production program relates to the production and sale of medical waste disposal containers that are treated in autoclaves by types: infectious, chemical and pharmaceutical, cytotoxic and pathoanatomical waste sharps bin.

These products include containers for medical waste in various volumes, then bags and labels for marking medical waste by species.

Containers for medical waste disposal – sharps bin, bags as well, are UN3291/ADR approved.