CE Zertifikat Europa, ausgestellt am 3. September 2009:
Produktions- und Qualitätsmanagement Zertifikat:
MedCert Zertifizierungs- und Prüfungsgesellschaft für die Medizin GmbH.
Benannte Stelle Kennn-Nummer: 0482
European Medical Devices Directive Annex V Certificate, No. 6408GB414090903, according to the Council Directive 93/42/EEC Medical Devices and EN ISO 13485:2003 + AC:2007 and Annex V, 93/42/EEC 3rd edition of the EN60601-1 Electrical Safety Directive, valid from 1 January 2010
Hersteller: AussiMed Engineering
Medizingerät: CyberTrone
Klassifikation: Klasse IIa
ACHTUNG:
Die Klassifizierung von Medizingeräten kann von Land zu Land unterschiedlich sein..
In EUROPE bedeutet die Klassifizierung CE IIa dass dieses Gerät für Diagnose und Therapie zugelassen ist. Eine Registrierung in dieser Klasse ist nur möglich, wenn der Nachweis der therapeutischen Wirksamkeit erbracht ist..
In den USA ist die Zulassung nach Klasse IIa völlig anders. Alles - vom Zungenspatel bis zum Röntengerät - wird dort in Klasse IIa erfasst. Nachstehend die Spezifikationen des FDA für Klasse IIa-Medizingeräte:
Medical Device Definition
Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines and medical lasers. If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration (FDA) as a medical device and is subject to premarketing and postmarketing regulatory controls. A device is:
"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
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MEDSAFE - WAND Neuseeland
Registrierung vom 28. Januar 2011 als Medizingerät der Klasse IIa
Registrier-Nummer 110113-WAND-6ADNS3
