EC CERTIFICATE

Product catalog summary

Certificate Overview: This document is an EC Certificate for the Production Quality Assurance System Approval issued to NORDITALIA GROUP SRL, located in Desenzano del Garda, Italy. It certifies the management of a quality assurance system in compliance with Directive 93/42/EEC for specific medical devices.

Certified Products: The certificate covers the following products:

Aerosoltherapy equipment and related accessories
Ultrasonic aerosoltherapy equipment and related accessories
Electronic thermometer
Non-invasive Sphygmomanometer

These products must meet the essential requirements of the directive throughout the manufacturing stage.

Certification Details:

The certificate is valid for class IIb devices only with the relevant certificate of Annex III.
It is subject to surveillance as specified in section 4 of Annex V.
Reference is made to IMQ files Nos: DM15A0528727-01, DM16A0584871-01, DM16-0000075, DM17-0009902-01, DM17-0012765.

Issuing Body: The certificate is issued by IMQ S.p.A., a Notified Body for Directive 93/42/EEC, notified to the European Commission under number 0051.

Validity and Updates:

Original issue date: 2000-01-31
Substitution date: 2017-04-21
Expiry date: 2021-04-05
Last updated: 2017-06-08

Additional Notes: The certificate is a translation of the Italian text, which prevails in case of discrepancies. The product types are referenced in the document "Elenco prodotti sotto marcatura CE", Rev. 34 dated 24/05/2017, and are valid only if provided with an IMQ stamp.

Catalog excerpts

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