CE Medical (Europe regions)
Within the European Union, the Scan Monitor is CE marked according to the Medical Device Directive 93/42/EEC as amended by the 2007/47/EC.
The European Notified Body responsible for the assessment of this product is Ente Certificazione Macchine, an Italian Notified body with the following identification number 1282.
The reference of the CE certificate is ECM19MDD008 rev. 4.
The related manufacturer declaration of conformity is here.
Australia & New Zealand
The Scan Monitor is registered within Australia and New-Zealand as a medical device.
Within Australia, the ARTG listing number is 343233
Within New-Zealand, the WAND reference is 200715-WAND-6V1QDY