EC Declaration of Conformity April 2016

EC Declaration of Conformity

4 Pages

Page 1 of 4  Product Group: Medical Aspirators Reference: See attached Schedule  EG KONFORMITÄTSERKLÄRUNG EC DECLARATION AND MANUFACTURER’S DECLARATION OF CONFORMITY CE DÉCLARATION DE CONFORMITÉ CE DICHIARAZIONE DI CONFORMITÀ Full quality assurance procedure Manufacturer's Name:  Medela AG  Business Address:  Lättichstrasse 4b, 6341 Baar, Switzerland  Medical Device(s):  Medical Aspirators - See attached Schedule  Classification:  Class IIa - See attached Schedule  GMDN Code and Term:  [36777] Suction system, general-purpose, line-powered [36778] Suction system, general-purpose, vacuum-powered [36787] Thoracic suction system [20395] Aspirators as part of Suction system, wound, powered [36894] Liposuction system - See Attached Schedule  Scope of Application:  - See Attached Schedule  Wir erklären in alleiniger Verantwortung, dass die Medizinprodukte der Klasse I, I steril und IIa – gemäss Anhang, auf die sich diese Erklärung bezieht, übereinstimmen mit den Bestimmungen der Richtlinie des Rates 93/42/EWG (2007/47/EG). Die Medizinprodukte sind konform mit den grundlegenden Anforderung gemäss Anhang I der Richtlinie. Das Konformitätsbewertungsverfahren wurde durchgeführt gemäss Anhang II (Klasse IIa), Anhang V (Klasse I steril) oder VII (Klasse I) der Richtlinie. Note for Australia only: This is a declaration made in accordance with the requirements of Clause 1.8 of Schedule 3 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002 relating to the devices stated in the attached Schedule. We declare under our sole responsibility, that the medical devices of class I, I sterile and IIa – see attached Schedule, to which this declaration relates are in conformity with the provisions of the Council Directive 93/42/EEC (2007/47/EC). The medical devices are in conformity with the essential requirements of Annex I of the EEC directive. The conformity assessment procedure was performed according to Annex II (class IIa), Annex V (class I sterile) or VII (class I) of the EEC directive. Nous déclarons sous notre seule responsabilité que les dispositifs médicaux de la classe I, I stérile et IIa – conformément au document ci-joint, auxquels se réfère cette déclaration sont conforme avec les dispositions de la Directive du Conseil 93/42/CEE (2007/47/CE). Les dispositifs médicaux sont conforme aux exigences essentielles de l'annexe I de la directive. La procédure d'évaluation de la conformité a été effectuée conformément à l'annexe II (classe IIa), l'annexe V (classe I stérile) ou VII (classe I) de la directive. Noi dichiariamo sotto la nostra sola responsabilità che i dispositivi medici della classe I, I sterile e IIa – secondo il documento allegato, ai quali questa dichiarazione si riferisce, è in conformità alle disposizioni della Direttiva del Consiglio 93/42/CEE (2007/47/CE). I dispositivi medici soddisfano i requisiti essenziali dell'allegato I della direttiva. La procedura di valutazione di conformità è stata effettuata in accordo all'allegato II (classe IIa), all'allegato V (classe I sterile) o VII (classe I) della direttiva. Full Quality Assurance System Certificate: TÜV Süd Product Service GmbH, No. G1 11 02 11634 102, Notified Body id no. 0123: European Medical Devices Directive Annex II excluding (4) (class IIa devices only) Full Production Quality Assurance Certificate: TÜV Süd Product Service GmbH, No. G2S 11 02 11634 101, Notified Body id no. 0123: European Medical Devices Directive Annex V (class I sterile devices only) Valid until:  2016-04-17  Notes: These standards do not necessarily apply to all parts of the product group in attached Schedule. The editions of above standards correspond with the harmonized standards, of which the reference numbers have been published in the Official Journal of the European Union. Authorised Signatories:  Markus Bütler, Vice President - Quality Mgmt & Regulatory Affairs Baar/Switzerland:  Gültig ab: Valid from: Valable dès: Valido dal:  Marcel Felber, President  February 01, 2013  2013-02-01, Mit dieser Ausgabe werden alle früheren Versionen ungültig 2013-02-01, With this edition, all former versions become invalid 2013-02-01, Avec cette édition, toutes les versions précédentes ne sont plus valables 2013-02-01, Con questa edizione, tutte le versioni precedenti diventano invalidi  EC_AUS_DoC MedicalAsprtrs_7_1_20130201.docx Templ. 7.1
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