Certified Quality System
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
EC Certificate number G2 17 12 31998 026
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.
EC Certificate number G2S 17 12 31998 027
Notified Body – TÜV SÜD Product Service GmbH
Product Categories: Oro-nasopharyngeal airway, breathing exercisers, laryngoscopy bite block, air management fixation devices, swabs for oral care. Enteral and rectal tubes.
Certificate 50 100 7082 Rev. 004 · UNI EN ISO 14001:2015
Notified Body – TÜV SÜD Product Service GmbH
DEAS is EN ISO 14001 Certified for: Design, development and production of sterile and not sterile medical devices and electromedical equipments made by injection moulding, extrusion, assembly and distribution. Mould assembling and maintenance
