FDA Registration Information:
Meditherm products are fully compliant with all regulatory requirements.
The Meditherm FDA Manufacturer registration number is : 3006111110.
You may begin a search of the FDA data base by going to: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/listing.cfm and, for example, enter “Meditherm” in the Establishment Name space and then click the ‘search’ button. Alternatively you can enter, “Med2000 IRIS” in the Proprietary Device Name space, to get the listing(s).
The EC Conformity classification is : MDD Annex IX, Rule12, Class 1. A full list of applied standards is available on request.