EC Declaration of Conformity April 2016 PDF download

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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Reference Article No. 014.0010 014.0011 014.0012 014.0013 014.0014 014.0015 014.0020 014.0040 014.0050 014.0110 014.0111 014.0112 014.0113 014.0114 014.0115 014.0120 014.0140 014.0150 014.0210 014.0211 014.0212 014.0213 014.0214 014.0215 014.0220 014.0230 014.0240 014.0250 020.0501 026.2110 026.2112 026.2113 026.2120 026.2140 026.2150 026.2160 026.9000 026.9001 026.9002 026.0006 026.0008 026.0007 026.5110 026.5112 026.5140 026.5150 026.5160 026.7110 026.7110 026.7112 026.7112 026.7140 026.7140 026.7150 026.7150 026.7160 026.7160 026.7170 026.7170 026.8113 026.8113 026.8121 026.8122 026.8122 026.8142 026.8142 026.8152

Description Clario Home Care Pump AC Version Clario Home Care Pump AC Version Clario Home Care Pump AC Version Clario Home Care Pump AC Version Clario Home Care Pump AC Version Clario Home Care Pump AC Version Clario Home Care Pump AC Version Clario Home Care Pump AC Version Clario Home Care Pump AC Version Clario Home Care Pump AC/DC Version Clario Home Care Pump AC/DC Version Clario Home Care Pump AC/DC Version Clario Home Care Pump AC/DC Version Clario Home Care Pump AC/DC Version Clario Home Care Pump AC/DC Version Clario Home Care Pump AC/DC Version Clario Home Care Pump AC/DC Version Clario Home Care Pump AC/DC Version Clario Home Care Pump Deluxe Version Clario Home Care Pump Deluxe Version Clario Home Care Pump Deluxe Version Clario Home Care Pump Deluxe Version Clario Home Care Pump Deluxe Version Clario Home Care Pump Deluxe Version Clario Home Care Pump Deluxe Version Clario Home Care Pump Deluxe Version Clario Home Care Pump Deluxe Version Clario Home Care Pump Deluxe Version Surgical Suction Pump Powered from a Pressure Source Vario Secretion Aspirator Vario Secretion Aspirator Vario Secretion Aspirator Vario Secretion Aspirator Vario Secretion Aspirator Vario Secretion Aspirator Vario Secretion Aspirator Vario Secretion Aspirator Vario Secretion Aspirator IKRK Vario Secretion Aspirator Vario 18 Given AC Medium Vacuum Aspirator Vario 18 Given AC Medium Vacuum Aspirator Vario 18 Given AC Medium Vacuum Aspirator Vario Secretion Aspirator AC/DC Vario Secretion Aspirator AC/DC Vario Secretion Aspirator AC/DC Vario Secretion Aspirator AC/DC Vario Secretion Aspirator AC/DC Vario Low Vacuum Aspirator Vario Low Vacuum Aspirator Vario Low Vacuum Aspirator Vario Low Vacuum Aspirator Vario Low Vacuum Aspirator Vario Low Vacuum Aspirator Vario Low Vacuum Aspirator Vario Low Vacuum Aspirator Vario Low Vacuum Aspirator Vario Low Vacuum Aspirator Vario Low Vacuum Aspirator Vario Low Vacuum Aspirator Vario 18 c/i Medium Vacuum Aspirator AC/DC Vario 18 c/i Medium Vacuum Aspirator AC/DC Vario 18 c/i Medium Vacuum Aspirator AC/DC Vario 18 c/i Medium Vacuum Aspirator AC/DC Vario 18 c/i Medium Vacuum Aspirator AC/DC Vario 18 c/i Medium Vacuum Aspirator AC/DC Vario 18 c/i Medium Vacuum Aspirator AC/DC Vario 18 c/i Medium Vacuum Aspirator AC/DC

Gültig ab: Valid from: Valable dès: Valido dal:

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

Product Group: Medical Aspirators Reference: See attached Schedule

Class GMDN IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36778 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36787 IIa 36777 IIa 36787 IIa 36777 IIa 36787 IIa 36777 IIa 36787 IIa 36777 IIa 36787 IIa 36777 IIa 36787 IIa 36777 IIa 20395 IIa 36777 IIa 36777 IIa 20395 IIa 36777 IIa 20395 IIa 36777

Effectivity point all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production

EC_AUS_DoC MedicalAsprtrs_7_1_20130201.docx Templ. 7.1

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Reference Article No. 026.8152 026.8152 026.5120 026.8111 026.8111 026.8120 026.8123 026.8123 026.8141 026.8141 026.8151 026.8151 026.8110 026.8110 026.8112 026.8112 026.8140 026.8140 026.8150 026.8150 037.0111 037.0112 037.0113 037.0114 037.0115 037.0122 037.0124 037.0214 037.0224 037.1111 037.1112 037.1113 037.1115 037.1124 037.1214 037.1224 037.2111 037.2112 037.2113 037.2115 037.2124 037.2214 037.2224 037.9000 057.4111 057.4111 057.4111 057.4112 057.4112 057.4112 057.4113 057.4113 057.4113 057.4114 057.4114 057.4114 057.4115 057.4115 057.4115 057.4116 057.4116 057.4116 057.4117 057.4117 057.4117 057.4118 057.4118

Description Vario 18 c/i Medium Vacuum Aspirator AC/DC Vario 18 c/i Medium Vacuum Aspirator AC/DC Vario 18 c/i Medium Vacuum Aspirator AC/DC Vario 8 c/i Low Vacuum Aspirator AC/DC Vario 8 c/i Low Vacuum Aspirator AC/DC Vario 8 c/i Low Vacuum Aspirator AC/DC Vario 8 c/i Low Vacuum Aspirator AC/DC Vario 8 c/i Low Vacuum Aspirator AC/DC Vario 8 c/i Low Vacuum Aspirator AC/DC Vario 8 c/i Low Vacuum Aspirator AC/DC Vario 8 c/i Low Vacuum Aspirator AC/DC Vario 8 c/i Low Vacuum Aspirator AC/DC Vario 8 Low Vacuum Aspirator AC/DC Vario 8 Low Vacuum Aspirator AC/DC Vario 8 Low Vacuum Aspirator AC/DC Vario 8 Low Vacuum Aspirator AC/DC Vario 8 Low Vacuum Aspirator AC/DC Vario 8 Low Vacuum Aspirator AC/DC Vario 8 Low Vacuum Aspirator AC/DC Vario 8 Low Vacuum Aspirator AC/DC Medela Basic 30 mobile Medela Basic 30 mobile Medela Basic 30 mobile Medela Basic 30 mobile Medela Basic 30 mobile Medela Basic 30 mobile Medela Basic 30 mobile Medela Basic 30 mobile Medela Basic 30 mobile Medela Basic 30 portable Medela Basic 30 portable Medela Basic 30 portable Medela Basic 30 portable Medela Basic 30 portable Medela Basic 30 portable Medela Basic 30 portable Medela Basic 30 Rack Medela Basic 30 Rack Medela Basic 30 Rack Medela Basic 30 Rack Medela Basic 30 Rack Medela Basic 30 Rack Medela Basic 30 Rack Medela Basic 30 IRCC Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i

Gültig ab: Valid from: Valable dès: Valido dal:

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

Product Group: Medical Aspirators Reference: See attached Schedule

Class GMDN IIa 36777 IIa 20395 IIa 20395 IIa 36777 IIa 36787 IIa 36777 IIa 36777 IIa 36787 IIa 36777 IIa 36787 IIa 36777 IIa 36787 IIa 36777 IIa 36787 IIa 36777 IIa 36787 IIa 36777 IIa 36787 IIa 36777 IIa 36787 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 36777 IIa 20395 IIa 36787 IIa 36777 IIa 20395 IIa 36787 IIa 36777 IIa 20395 IIa 36787 IIa 36777 IIa 20395 IIa 36787 IIa 36777 IIa 20395 IIa 36787 IIa 36777 IIa 20395 IIa 36787 IIa 36777 IIa 20395 IIa 36787 IIa 36777 IIa 20395 IIa 36787

Effectivity point all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production

EC_AUS_DoC MedicalAsprtrs_7_1_20130201.docx Templ. 7.1

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Reference Article No. 057.4118 057.4118 057.4121 057.4121 057.4121 057.4214 057.4214 057.4214 057.4224 057.4224 057.4224 057.4225 057.4225 057.4225 057.5111 057.5111 057.5111 057.0111 057.0111 057.0111 057.0112 057.0112 057.0112 057.0113 057.0113 057.0113 057.0114 057.0114 057.0114 057.0115 057.0115 057.0115 057.0124 057.0124 057.0124 057.0214 057.0214 057.0214 057.0224 057.0224 057.0224 057.2111 057.2111 057.2111 057.2112 057.2112 057.2112 057.2113 057.2113 057.2113 057.2115 057.2115 057.2115 057.2124 057.2124 057.2124 057.2214 057.2214 057.2214 057.2224 057.2224 057.2224 079.0000 079.0002 079.0003

Description Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 35 c/i Medela Dominant 50 mobile Medela Dominant 50 mobile Medela Dominant 50 mobile Medela Dominant 50 mobile Medela Dominant 50 mobile Medela Dominant 50 mobile Medela Dominant 50 mobile Medela Dominant 50 mobile Medela Dominant 50 mobile Medela Dominant 50 mobile Medela Dominant 50 mobile Medela Dominant 50 mobile Medela Dominant 50 mobile Medela Dominant 50 mobile Medela Dominant 50 mobile Medela Dominant 50 mobile Medela Dominant 50 mobile Medela Dominant 50 mobile Medela Dominant 50 mobile Medela Dominant 50 mobile Medela Dominant 50 mobile Medela Dominant 50 mobile Medela Dominant 50 mobile Medela Dominant 50 mobile Medela Dominant 50 Rack Medela Dominant 50 Rack Medela Dominant 50 Rack Medela Dominant 50 Rack Medela Dominant 50 Rack Medela Dominant 50 Rack Medela Dominant 50 Rack Medela Dominant 50 Rack Medela Dominant 50 Rack Medela Dominant 50 Rack Medela Dominant 50 Rack Medela Dominant 50 Rack Medela Dominant 50 Rack Medela Dominant 50 Rack Medela Dominant 50 Rack Medela Dominant 50 Rack Medela Dominant 50 Rack Medela Dominant 50 Rack Medela Dominant 50 Rack Medela Dominant 50 Rack Medela Dominant 50 Rack Medela THOPAZ Medela THOPAZ Medela THOPAZ

Gültig ab: Valid from: Valable dès: Valido dal:

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

Product Group: Medical Aspirators Reference: See attached Schedule

Class GMDN IIa 36787 IIa 36777 IIa 20395 IIa 36787 IIa 36777 IIa 20395 IIa 36787 IIa 36777 IIa 20395 IIa 36787 IIa 36777 IIa 20395 IIa 36787 IIa 36777 IIa 20395 IIa 36787 IIa 36777 IIa 36787 IIa 36777 IIa 36894 IIa 36787 IIa 36777 IIa 36894 IIa 36787 IIa 36777 IIa 36894 IIa 36787 IIa 36777 IIa 36894 IIa 36787 IIa 36777 IIa 36894 IIa 36787 IIa 36777 IIa 36894 IIa 36787 IIa 36777 IIa 36894 IIa 36787 IIa 36777 IIa 36894 IIa 36787 IIa 36777 IIa 36894 IIa 36787 IIa 36777 IIa 36894 IIa 36787 IIa 36777 IIa 36894 IIa 36787 IIa 36777 IIa 36894 IIa 36787 IIa 36777 IIa 36894 IIa 36787 IIa 36777 IIa 36894 IIa 36787 IIa 36777 IIa 36894 IIa 36787 IIa 36787 IIa 36787

Effectivity point all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production all production

EC_AUS_DoC MedicalAsprtrs_7_1_20130201.docx Templ. 7.1