Specifications
Active, non-implantable diagnostic medical device class I with a measuring function
according directive 93/42/EEC.
For Germany only:
Is not listed in app. 1 or 2 of MPBetreibV (Medizinprodukte–Betreiberverordnung) and
therefore need:
no field check by the manufacturer (§ 5)
no induction course (§ 5)
no safety checks according § 6 but only the maintenance checks (§ 4) or metrological
controls (§ 11) that enjoined by the manufacturer
no registration in the medical devices book (§ 7)
However the device mentioned above needs a registration in the active medical products
inventory of the unit according to § 7 MPBetreibV or into another, equivalent directory.