ActiGraph LEAP - Page 29

Regulatory Information
| Continued
Emergo Europe
Westervoortsedijk 60
6827 AT Arnhem
The Netherlands
AUSTRALIAN SPONSOR
Emergo Australia
Level 20, Tower II
Darling Park
201 Sussex Street
Sydney NSW 2000
Australia
Emergo Consulting (UK)
Limited
c/o Cr360 – UL
International
Compass House, Vision
Park Histon
Cambridge CB24 9BZ
United Kingdom
Authorized Representative in European
Community
ActiGraph’s Australia Sponsor
Indicates ActiGraph’s authorized Australian Sponsor.
ActiGraph’s United Kingdom Sponsor
Indicates ActiGraph’s authorized United Kingdom Sponsor.
Catalog Number
Indicates the manufacturer’s catalogue number so that the medical device can
be identified for reordering.
CE Symbol
By affixing the CE marking to a product, a manufacturer declares that the
product
meets all the legal requirements for CE marking and can be sold throughout
the
EEA. ActiGraph’s products abide with the Medical Device Directive 93/42/EEC
and Radio Equipment Directive 2014/53/EU.
Brazil National Telecommunications Agency (ANATEL)
Homologação Number
This equipment operates on a secondary basis, that is, not entitled to
protection
from harmful interference, even for stations of the same type, and may not
cause
interference to systems operating on a primary basis.
XXXXX-XX-XXXXX
“Este equipamento não tem direito à proteção contra
interferência prejudicial e não pode causar interferência em
sistemas devidamente autorizados. Para maiores
informações, consulte o site da ANATEL –
www.anatel.gov.br
”
Consult Instructions for Use
Indicates the need for the user to consult the instructions for use.
Serial Number
Indicates the manufacturer’s serial number so that a specific medical device
can
be identified. The manufacturing date is included in the serial number.
STM2XXXXXXXX
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ACTIGRAPH LEAP™ | E.200.6025 | RELEASED: 10/09/2023 | REV: 0
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