Vantaggi-del-leader

The market-leader advantages

All products manufactured by Synergic Italiana are class 1 medical devices, CE marked as provided by Medical Device class 1 MDR UE 2017/745 and subsequent modifications and additions. 

. We devote great attention to safety and quality, at both the design and production stags: our products comply with the most stringent standards related  to fire prevention (type-approved by the Ministry of Interior in class 1IM for fire reaction, in compliance with CSE RF 4/83, DM 26/06/84, integrated with  UNI 9175 and UNI 9175/FA1DM 03/09/2001 regulations and subsequent amendments and additions.

All materials employed by Synergic Italiana for the manufacture of the products are Latex-Free. Paddings are assembled without the use of glues or other chemical binders.

The organizational, management, industrial and commercial procedures of Synergic Italiana are outlined in the quality assurance manual and are certified according to UNI EN ISO 9001 and UNI CEI ISO 13485, as a medical devices manufacturer.

Our static-reactive mattresses provide comfort and perform primary prevention of bedsores, according with ErgoCert Technical Regulation referred to the ergonomic features required in the biomedical field and they are certified by suitable test certification.

The performance requirements referred to non-deformability and durability of all our specialised mattresses are certified in compliance with UNI 10707 rev. 2003 by LAPI, an important medical and certification laboratory, at the highest severity level (45000 cycles).

All raw materials employed by Synergic Italiana undergo a sanitation treatment during production, able to prevent from the formation of bacterial and fungal load through a bacteriostatic and fungistatic activity.

The monitoring of proliferation of bacteria, fungi and mould, leads to a remarkable improvement of the patient’s hygiene and also contributes to eliminating unpleasant odours.

As a result, the best hygienic conditions for both the patient and the healthcare professional, are guaranteed. Moreover, the sanitation treatment protects the materials from premature ageing, humidity and heat.

Synergic Italiana has developed an extremely innovative material for the manufacture of mattresses high-technology products: Synergel®. An international trademark for a unique material which has become synonymous with technology and comfort for specialised and at-risk hospitalizations.

As the Italian market leader, Synergic Italiana supplies static-reactive mattresses, pillows and decubitus aids made from Synergel® and techno-polymers, to most of the main Italian hospitals and health facilities as well as in several foreign countries.

Health communities and companies operating in the hospital integrated services sector, are constantly struggling with the serious managerial and economic problem of the sanitation and severe epidemiological treatment, aimed at the disinfection of mattresses and pillows. All of our products allow us to solve such problem: thanks to the raw materials employed and their innovative and exclusive adhesive-free modular structure, any modern and cutting edge sanitation and disinfection treatment can be performed on our products.

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Our Certifications

materassi certificati ce

Medical Device class 1 MDR UE 2017/745 and subsequent modifications and additions

materassi igienici e trattamento sanitario permanente

Hygiene and permanent
Sanitation Treatment

materassi latex free senza lattice

Latex-free
Products

materassi e prodotti ergonomici certificati

Ergonomic mattresses
certified by Ergocert

Requisiti prestazionali certificati

Performance Requirements
UNI 10707 REV2003

Azienda certificata iso 9001:2008

ISO9001
ISO13485

Azienda certificata iso 9001:2008

ACCREDIA