CE Certification Europe, issued 3 September 2009:
Production Quality Management System Certificate:
MedCert Zertifizierungs- und Prüfungsgesellschaft für die Medizin GmbH.
Notified body no: 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
Manufacturer's Name: AussiMed Engineering
Medical Device: CyberTrone
Classification: Class IIa
ATTENTION:
The classification as a medical device may vary from country to country.
In EUROPE a medical device CE Class IIa is fit for diagnosis and treatment. To register as a Class IIa medical device proof of therapeutic effectiveness must be provided.
In the US a medical device FDA Class IIa is different. Following the specification from FDA:
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 New Zealand
Registration from 28 January 2011 as Medical Device class IIa
Registration-No 110113-WAND-6ADNS3
