Certified Quality System

Deas Quality Certification

EN ISO 9001:2008 Certificate n. 50 100 5973

Certification body – TÜV Italia Srl

DEAS maintains a quality system Certified UNI EN ISO 9001:2008 for:

Design and development, manufacturing and distribution of sterile and non sterile medical devices for Respiratory, Airway Management, Surgical suction and Gastroenterology. Design and development, manufacturing and distribution of electromedical equipment: Humidifiers for pulmonary ventilation

EN ISO 13485 Certificate n. Q1N 15 05 31998 024

Certification body – TÜV SÜD Product Service GmbH

DEAS is EN ISO 13485 Certified for: Design and development, manufacturing and distribution of sterile and non sterile medical devices for Respiratory, Airway Management, Surgical suction and Gastroenterology. Design and development, manufacturing and distribution of electromedical equipments: Humidifiers for pulmonary ventilation

DEAS CE Mark

Within the European Union, EU, conformity of products and the proper application of the CE marking to medical devices is necessary for marketing. The intent is to ensure compliance with all relevant EU Directives.

Background

The guarantee of free trade of goods within the Community is the most important objective. This will eliminate trade restrictions that result from different technical regulations in each individual member country. Harmonization of existing European standards and regulations, is being accomplished and already partially realized. Based on this goal, a new concept for creating directives was formed in 1985 by the European Community (EC) Commission to produce directives with a wide range of application which contain only the most basic safety requirements.

The CE Mark

The CE mark is prescribed by law and assures the European free trade of goods. It is short for ”Communauté Européen”, and is displayed on goods and/or packaging which acts as an external symbol for the inspection of products. It also illustrates the manufacturer’s responsibility to uphold the community’s directives.

DEAS’ commitment to the directives

DEAS will attach the CE mark in accordance with the product directives. Our products will conform as follows:

  • Declarations of conformity for DEAS products will be available when required by the relevant EU directives
  • Those products required to do so will bear CE marking as specified by the relevant EU directives and CE marking regulations
  • Necessary technical documentation will be on file and made available to authorized organizations upon written request

CE Certificate number G2S 14 12 31998 023

Notified Body – TÜV SÜD Product Service GmbH

Product Categories: Oro-nasopharyngeal airway, endoscopy bite block, air management fixation devices, Enteral and rectal tubes.

CE Certificate number G2 14 10 31998 022

Notified Body – TÜV SÜD Product Service GmbH

Product Categories: Sterile and non sterile medical devices: breathing circuits and connectors, humidification chambers, catheters mount, masks, filters, spirometry filters and mouthpieces, bags and manual breathing units, monitor lines, extraglottic, tracheal, tracheal-bronchial, tracheostomy tubes and introducers, aerosol and oxygen therapy devices, PEEP valves; suction devices.

CE Certificate number G113 02 31998 019

Notified Body – TÜV SÜD Product Service GmbH

Product Categories: Humidifiers for pulmonary ventilation

All information in this website has no contractual value. It concerns medical devices that can only be used by healthcare professionals. Unqualified operators/entities are not entitled to use such information. Deas does not respond to any technical or commercial information request arising from patients.