This page lists all the Certifications held by Wunder Sa.Bi. Srl and the symbols used on the websites:

wunder.it | medicale.wunder.it | industriale.wunder.it | design.wunder.it

CERTIFICATIONS
Certificate	Certification Body	Description
		Wunder complies with the ISO 9001:2015 standard, which certifies the Design, Production, and Assistance of medical and industrial scales, as well as the Commercialization and Assistance of domestic and industrial scales.
		The ISO 13485:2016 standard defines the requirements for a quality management system for medical device manufacturers. As manufacturers of medical devices, we ensure that our products are designed, manufactured, and marketed according to the standards set by the standard, in order to meet the specific requirements of the market and relevant laws.
		Wunder holds the CE Certificate of Quality Assurance System Approval as a manufacturer of instruments approved or approvable for legal use in relations with third parties in compliance with Directive 2014/31/EU and the European standard EN45501. The metrological marking indicates that the instrument has a certificate of approval or type examination, issued by the European Notified Body, which validates its suitability for legal use.
		Wunder manufactures instruments with CE marking in compliance with Directive 93/42/EEC. To be freely sold within the European Union and EFTA, medical devices must comply with the relevant product directives and bear the CE mark.
		The HACCP - Europe (HCV EU) compliance verification program verifies the hygienic quality of commercial food equipment. With this all-inclusive program, manufacturers can demonstrate their commitment to food safety and compliance with relevant European guidelines and regulations.
		As producers of Electrical and Electronic Equipment, we are registered with the Register of Battery and Accumulator Producers, which regulates and monitors the placement on the market and proper disposal of such equipment.
		As producers of Electrical and Electronic Equipment (EEE), we are registered with the EEE Register, which regulates and monitors the EEE market.
		The National Packaging Consortium has marked the transition from a landfill-based management system to an integrated system, which focuses on prevention, recovery, and recycling of the six packaging materials: steel, aluminum, paper, wood, plastic, and glass.

LEGEND OF SYMBOLS
	The 'CE 0476' marking indicates that the instrument is a Medical Device compliant with Directive 93/42/EEC.
	The 'CE 0474' metrological marking indicates that the instrument has a certificate of approval or type examination, issued by the European Notified Body, which validates its suitability for legal use, in compliance with Directive 2014/31/EU and the European Standard EN45501. This approval is essential for the use of the instrument in the medical and healthcare sector.
	Medical Device MDD compliant with Directive 93/42/EEC
	Instrumentation compliant with NAWI Metric Directive Class I 90/384-2014/31/EU and Standard EN45501
	Instrumentation compliant with NAWI Metric Directive Class II 90/384-2014/31/EU and Standard EN45501
	Instrumentation compliant with NAWI Metric Directive Class III 90/384-2014/31/EU and Standard EN45501
	Instrumentation compliant with NAWI Metric Directive Class IV 90/384-2014/31/EU and Standard EN45501
	As a manufacturer of instruments used in contact with food, our products are MOCA certified. MOCA refers to all materials and objects intended to come into contact with food and must comply with community production standards (Regulation EC 1935/2006).
	Product compliant with the European HCV directive (HACCP Compliance Verification) for food contact materials and hygienic design.
	Instrumentation with Bluetooth connectivity (BLE)
	Document in Italian
	Document in English
	Document in French
	Document in Spanish
	Document in German
	Document in Arabic
	Multilingual Document
	PDF file icon for downloading attachments