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10. Symbols Used on Labels
10-1 UDI Label (Packing Box)
Legal manufacturer
Medical device
Serial number
Authorized representative for EU countries
The maximum and minimum temperatures for
storing, transporting, and using the product.
Declaration of conformity according to the
European Regulation 2017/745
Single patient multiple use
10-2 Body Mass Limit Label (Knee Joint Body)
■
K Level (MOB)
K1 Level (MOB1): User can move to a bed or
chair, and can walk on a flat surface indoors at a
constant speed.
K2 Level (MOB2): User can handle small environ-
mental barriers such as curbs, steps, or irregular
ground both indoors and around the home.
K3 Level (MOB3): User can handle most environ-
mental barriers, and can walk at different speeds.
In addition to simple walking, he/she can do light
work and exercise as well.
K4 Level (MOB4): User has physical abilities
higher than basic walking; children, athletes, etc.
10-3 Product Type Label (Knee Joint Body)
A
B
Declaration of conformity according to
the European Regulation 2017/745
Made date
Item number
Global Trade
Item Number
Body mass limit not
to be exceeded.
A Product type
B Serial number
EN – 26
P.28