EG KONFORMITÄTSERKLÄRUNG EC DECLARATION AND MANUFACTURER S DECLARATION OF CONFORMITY CE DÉCLARATION DE CONFORMITÉ CE DICHIARAZIONE DI CONFORMITÀ
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1 Page 1 of 5 Manufacturer's Name: Business Address: Medical Device(s): Classification: GMDN Code and Term: Scope of Application: EG KONFORMITÄTSERKLÄRUNG EC DECLARATION AND MANUFACTURER S DECLARATION OF CONFORMITY CE DÉCLARATION DE CONFORMITÉ CE DICHIARAZIONE DI CONFORMITÀ Medela AG Full quality assurance procedure Lättichstrasse 4b, PO Box 353, 6341 Baar, Switzerland General Aspirator Accessories - See attached Schedule Class I, IIa - See attached Schedule [16779] Suction system tubing [17115] Battery charger [20395] Suction system, wound, powered [34858] Suction system canister, single-use [36777] Suction system, general-purpose, line-powered [36787] Gauge as part of Thoracic Suction system [37040] Anaesthesia breathing tube holder [37075] Mount, general-purpose - See Attached Schedule [37798] Suction system filter, microbial [38476] Suction system bottle [42446] Suction system canister/bottle holder [43324] Fluid transfer set, general-purpose [44942] Suction system canister liner [44943] Suction system canister, reusable [46215] Drainage system fluid collector, pleural - 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). Each kind of medical device to which the Full Quality Assurance Procedures have been applied complies with the applicable provisions of the essential principles, the classification rules, at each stage, from the design of the device until its final inspection before being supplied. 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. G , 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 , Notified Body id no. 0123: European Medical Devices Directive Annex V (class I sterile devices only) Standards Applied: ISO IEC IEC IEC IEC ISO ISO series ISO ISO 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 Date: August 22, 2011 Marcel Felber, President
2 Page 2 of Holders and Clampholders I all production Holders and Clampholders I all production Holders and Clampholders I all production Holders and Clampholders I all production Holders and Clampholders I all production Holders and Clampholders I all production Holder with standard rail I all production Clampholder CH I all production Clamp holder for foreign jars I all production Safety device I meas. func all production Safety device I meas. func all production Safety device I meas. func all production Suction jar, polysulfone I meas. func all production Suction jar, polysulfone I meas. func all production Suction jar, polysulfone I meas. func all production Suction jar, polysulfone I meas. func all production Suction jar, polysulfone I meas. func all production Suction jar, polysulfone I meas. func all production Thorax jar PSU 1 litre I meas. func all production Suction jar, polycarbonate I meas. func all production Suction jar, polycarbonate I meas. func all production Suction jar, polycarbonate I meas. func all production Suction jar, polycarbonate I meas. func all production Suction jar, polycarbonate I meas. func all production Suction jar, polycarbonate I meas. func all production Suction jar, polycarbonate I meas. func all production Suction jar, polycarbonate I meas. func all production Suction jar, polycarbonate I meas. func all production Suction jar, polycarbonate 1,5L, Flexibag I all production Suction jar, polycarbonate 2,5L, Flexibag I all production Disposable suction bag I all production Disposable suction bag I all production Disposable suction bag I all production Disposable suction bag I all production Disposable suction bag I all production Disposable suction bag I all production Disposable suction bag I all production Disposable suction bag I all production Disposable suction bag I all production Disposable suction bag 1,5L, Flexibag I all production Disposable suction bag 2,5L, Flexibag I all production Disposable Suction Bag with Solidifier I all production Disposable Suction Bag with Solidifier I all production Disposable Suction Bag with Solidifier I all production Disposable Suction Bag with Solidifier I all production Disposable Suction Bag with Solidifier I all production Disposable Suction Bag with Solidifier I all production Disposable Suction Bag with Solidifier I all production Disposable Suction Bag with Solidifier 1,5L, Flexibag I all production Disposable Suction Bag with Solidifier 2,5L, Flexibag I all production Large lid with conical patient connection I all production Large lid with conical patient connection I all production Large lid with conical patient connection I all production Lid for disposable suction bag I all production Thorax lid 1 litre IIa all production Small lid with conical patient connection I all production Small lid with conical patient connection I all production Lid for safety jar I all production Trolley I all production Trolley small I all production Trolley, stainless steel I all production Trolley for Basic 30 and Dominant 50 I all production Trolley for Dominant 35ci I all production Wall bracket I all production Wall bracket I all production Disposable / Reusable serial connector I all production Drainage set I meas. func all production
3 Page 3 of Drainage set I meas. func all production Drainage set I meas. func all production Drainage set I meas. func all production Change-over valve I all production Change-over valve I all production Disposable specimen cup I all production Disposable specimen cup I all production Disposable bacteria filter I all production Disposable bacteria filter I all production Disposable bacteria/odour filter I all production Disposable bacteria/odour filter I all production Disposable overflow protection/bacteria filter I all production Disposable overflow protection/bacteria filter I all production Fiterset Vario with 5 disposable overflow protection/bacteria filter I all production Disposable overflow protection/bacteria filter (20 pcs) I all production Disposable overflow protection/bacteria filter I all production Disposable overflow protection/bacteria filter I all production Bacteria filter autoclavable I all production Disposable particle filter I all production Reusable set 1/2/3/5 liter I meas. func all production Reusable set 1/2/3/5 liter I meas. func all production Reusable set 1/2/3/5 liter I meas. func all production Reusable set 1/2/3/5 liter I meas. func all production Reusable set 1/2/3/5 liter I meas. func all production Reusable set 1/2/3/5 liter I meas. func all production Reusable set 1/2/3/5 liter I meas. func all production Reusable set 1/2/3/5 liter I meas. func all production Reusable set 1/2/3/5 liter I meas. func all production Foot switch ON/OFF I all production Foot switch ON/OFF I all production Foot switch ON/OFF I all production Foot vacuum regulator I all production Low vacuum regulator direct I all production Tubing holder I all production Tubing holder I all production Tubing holder I all production Tubing holder I all production Disposable set 1 l I meas. func all production Vario rail holder I all production Vario rail holder I all production Vario rail holder I all production Vario universal holder I all production Vario trolley plate I all production Vario holder fixed I all production Vario carrying bag I all production Mains cable for Basic 30 / Dominant 50 w. equipotentiality cable 5m I all production Car connection cable 12 VDC Vario I all production Vario disposable filter set with overflow protection/bacteria filter I all production Vario disposable filter set with overflow protection/bacteria filter I all production Disp. overflow protection/bacteria filter Medela & conical connection I all production Disp. overflow protection/bacteria/odor filter with Medela connection I all production Silicon tubing with/without 1/2 coupling piece I all production Silicon tubing with/without 1/2 coupling piece I all production Silicon tubing with/without 1/2 coupling piece I all production Silicon tubing with/without 1/2 coupling piece I all production Silicon tubing 12x7, 33cm, with coupling piece I all production Silicon tubing with/without 1/2 coupling piece I all production Silicon tubing with/without 1/2 coupling piece I all production Silicon tubing with/without 1/2 coupling piece I all production Silicon tubing with/without 1/2 coupling piece I all production Silicon tubing with/without 1/2 coupling piece I all production Silicon tubing with/without 1/2 coupling piece I all production Silicon tubing with/without 1/2 coupling piece I all production Tubing I all production Tubing 12x6,5 mm / 180 cm with coupling piece I all production Tubing sterile 12x6,5 mm / 200 cm with coupling piece I sterile all production Tubing 12x6,5 mm / 200 cm with coupling piece I all production
4 Page 4 of Tubing 12x6,5 mm / 200 cm with coupling piece I all production Tubing set for double drainage I all production Tubing I all production Disposable Tubing 180 cm with fingertip, sterile I sterile all production Disposable Tubing 180 cm, without fingertip I all production Disposable Tubing 150cm with 2 catheter connectors, sterile I sterile all production Angle piece I all production Angle piece I all production Y-piece (10 pcs) I all production Coupling / Coupling piece 90 I all production Coupling / Coupling piece 90 I all production Coupling / Coupling piece 90 I all production Coupling / Coupling piece 90 I all production Coupling / Coupling piece 5mm I all production Coupling I all production Conical Double Connector I all production Overflow protection device I all production Drainage valve I all production Plug for FMS lids I all production Disposable hydrofobic filter I all production Bellow for drainage valve I all production TDS Trolley with infusion holder I all production TDS Trolley with infusion holder I all production TDS Trolley with infusion holder I all production TDS Trolley with infusion holder I all production Suction jar, polysulfone I meas. func all production Suction jar, polysulfone I meas. func all production Olympus K Disposable suction bag I all production Olympus K Disposable suction bag I all production Olympus K Disposable Suction Bag with Solidifier I all production Olympus K Disposable Suction Bag with Solidifier I all production Olympus K Disposable Suction Bag with Solidifier I all production Olympus K Lid for disposable suction bag I all production Olympus K Large lid with conical patient connection I all production Medtronics Kit 1 IIa all production Medtronics Kit 2 IIa all production Starter Kit - Disposable Collection System IIa all production Given Vario Pump Kit IIa all production Lid with Mech. Overflow Protection Device IIa all production Lid with Overflow Sensor and Mech. Overflow Protection IIa all production Disposable dust cover for suction pumps I all production Suction Container Polysulfone I meas. func all production Suction Container Polysulfone I meas. func all production Holder for quiver / Quiver I all production Holder for quiver / Quiver I all production Holder for quiver / Quiver I all production Holder for quiver / Quiver I all production Holder for quiver / Quiver I all production Disposable canister for thorax drainage, sterile I sterile all production Disposable canister for thorax drainage, sterile I sterile all production Gauge for disposable canister I all production THOPAZ disposable canister 0.3l I sterile all production THOPAZ disposable canister with solidifier 0.3l I sterile all production THOPAZ disposable canister 0.8l I sterile all production THOPAZ disposable canister with solidifier 0.8l I sterile all production THOPAZ tubing set I sterile all production THOPAZ tubing set double I sterile all production Thorax Set 1 or 2 chamber system I meas. func all production TDS Basic 1 or 2 chamber system I meas. func all production Safety device set Vario ICRC I meas. func all production Clario Car connection cable 12 VDC I all production Clario Canister set I all production Clario SafetyChamber I all production Clario Set incl. SafetyChamber,canister and dispos. fingertip tubing I sterile all production Clario SoftCase I all production Carrying Strap I all production Adapter Vario I all production
5 Page 5 of Adapter Vario I all production Disposable specimen cup for disposable system I all production Serial connection vacuum Disposable System I all production Serial connection patient Disposable System I all production Serial connection patient I all production Vacuum tubing for serial connection of 4 suction liners I all production Patient tubing for serial connection of 4 suction liners I all production Y-piece 7/5 mm Disposable System I all production Holder 10x25 for 1 liter suction jar I all production Docking Station I all production Docking Station I all production Thopaz cap I sterile all production
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