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ABOUT OMNIA 

Founded in 1990, Omnia SPA is now a leading company for disposable medical devices. The company's headquarters are in Italy, but through its dealers, the company's products are now available in 50 countries all over the world. As a worldwide producer in Custom Sterile Procedure kits, Omina is committed to quality. Omnia has been providing Sutures to dental clinics for over 20 years.

Legislation and traceability:

The production of Omnia’s kits is classified in a controlled environment “ISO Class 8” in accordance to EN ISO 14644-1. The sets are packed in a double sterile packaging, paper, blister and medical packaging is completed in our clean room in accordance with very strict and rigorous procedures, in order to respond to the standard controls of the highest microbial and particulate load.

Our sets are devices produced in compliance with the rules of Directive 93/42/EEC concerning medical devices(updated and amended by Directive 2007/47/
EC) and the requirements of UNI EN ISO 13485:2004. Traceability is a procedure that allows us to reconstruct with ease and precision all the phases of the
production process (from the entrance of raw materials/ components, to sterilization) through registration on paper and / or computer for proper data storage and preservation.

The ‘label used by Omnia for sterile kits contains all the information you need to identify the device (code, lot, expiration date); there are two more cut-outs for the end user that allow easy data storage and traceability also by end customer.

The production of Omnia’s sutures is classified in a controlled environment “ISO Class 8” in accordance to EN ISO14644-1.:

1. Our sutures are devices produced incompliance with the rules of Directive 93/42/EEC concerning medical devices(updated and amended by Directive 2007/47/ EC) and the requirements of UNI EN ISO 13485:2012.

2. The sutures are packed in blister of medical paper and plastic film in accordance with very strict and rigorous procedures, in order to respond to the standard controls of the highest microbial and particulate.

3. The sutures are supplied in sterile and single used packaging , sterilized using ethylene oxide according to ISO 11135-1.

4. The sutures are in compliance with technical standards: USP 861 suture diameter; USP 871 suture-needle attachment  and USP 881 tensile strength.