3
Glossary of Symbols
The following labels and symbols may be affixed to the
UltraPro S100
system:
Symbol
Standard Reference
Standard Title
of Symbol
Symbol Title
as per
Referenced
Standard
Explanation
ISO 15223-1
Symbol 5.7.7
Medical devices
— Symbols to be
used with
information to be
supplied by the
manufacturer —
Part 1: General
requirements
An indication
of Medical
Device
This product is a
medical device.
Medical Device
Directive 93/42/EEC
or
Medical Device
Regulation 2017/745
as applicable
Council Directive
93/42/EEC
Regulation (EU)
2017/745
CE Marking of
Conformity
Signifies European
technical conformity.
Notified body
number appears
under symbol if
applicable.
ISO 15223-1
Symbol 5.1.2
Medical devices
— Symbols to be
used with
information to be
supplied by the
manufacturer —
Part 1: General
requirements
Authorized
representative
in the
European
Community
Indicates the
Authorized
representative in the
European
Community.
(www.gov.uk/guidance)
UKCA Mark
UKCA Mark
Signifies Great Britain
(England, Wales, and
Scotland) conformity.
UK Approved Body
number appears
under symbol.
Swiss Medical Device
Ordinance (MedDO)
Swiss Authorized
Representative
Swiss
authorized
representative
Indicates the
Authorized
representative in
Switzerland.
