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CE Medical (Europe regions)

Within Europe, 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.

The related manufacturer declaration of conformity is here.


Canada

The ScanWatch complies with RSS-102 and RSS-247 standards related to radio frequencies.

Its IC ID is 11411A-HWA09

 

Japan

The ScanWatch complies with Japanese Equipment Radio regulations.

Its ID is scanwatch-id-ja.png

 

Australia & New Zealand

The Scan Monitor is registered within Australia and New-Zealand as a medical device.

Within Australia, the ARTG listing number is 342233

Within New-Zealand, the WAND reference is 200715-WAND-6V1QDY

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