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CE Medical Certification Tyro Remotes

CE Medical Certification Tyro Remotes

When you use radio or telecommunication equipment as part of your active medical devices, this equipment is only allowed onto the European market if it complies with the R&TTE Directive (99/5/EC).

Active medical devices are only allowed onto the European market if they comply with Directive IEC 601 (IEC 60601) as part of the CE certification.

KEMA has been officially appointed to carry out the assessment of conformity with regard to the R&TTE Directive (99/5/EC) and the IEC 601 standard (IEC 60601) for access to the EU market. It has laboratories everywhere where these tests can be carried out. KEMA is also accredited for granting access to the markets of other countries.  

Al Tyro Remotes' products have this quality label.