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EU/EC Declaration of Conformity for CE Marking
We
ActivBody Inc.
4350 Executive Drive, Suite 200,
San Diego, CA 92121, USA
declare under our responsibility that the following product:
Model: ActivM2
Product name: ActivForce 2
is in conformity with the RADIO EQUIPMENT DIRECTIVE (RED) 2014/53/EU
and the following harmonized standards and technical specifications have been applied:
HEALTH and SAFETY (article 3.1a):
1) IEC 62368-1:2023
2) EN 62368-1:2024+A11:2024
3) IEC 60601-1:2005 (medical)
4) IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 (medical)
5) EU Human Exposure to Electromagnetic fields according to EN 62479:2010, EN 50663:2017
RF SPECTRUM AND EMC (articles 3.1b and 3.2):
1) ETSI EN 301 489-1 V2.2.3 (2019): Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 1
2) ETSI EN 301 489-17 V3.2.4 (2020): Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 17
3) EU EMC directive 2014/30/EU (medical):
3.1) EN 60601-1-2:2015+A1:2021
3.2) EN 60601-2-10:2015+A1:2016 Clause 201.17 and 202
3.3) EN 60601-1-11:2015+A1:2021 Clause 12
4) RED directive: RF Testing: ETSI EN 300 328 v 2.2.2 (2019): Wideband transmission systems; Data transmission equipment operating in the 2.4 GHz ISM band
RoHS COMPLIANCE:
1) EU RoHS: European Union Directive 2011/65/EU (RoHS 2) Annex II + Amendment Directive 2015/863/EU (RoHS 3). Lead present in copper alloy (brass) internal mechanical components is exempt under Annex III, Exemption 6(c) (lead in copper alloy up to 4% by weight).
Signed for and on behalf of: ActivBody Inc.:
Jonathan Tait, CEO
March 16, 2026
We
ActivBody Inc.
4350 Executive Drive, Suite 200,
San Diego, CA 92121, USA
declare under our responsibility that the following product:
Model: Activ5-M
Product name: ActivForce 2
is in conformity with the RADIO EQUIPMENT DIRECTIVE (RED) 2014/53/EU
and the following harmonized standards and technical specifications have been applied:
HEALTH and SAFETY (article 3.1a):
1) IEC 62368-1:2014 (Second Edition): Audio/Video, information, and communication technology equipment Part 1: Safety requirements, CB report
2) EU group/national differences: requirements of EN 62368-1 2014+A11:2017
3) EU RF Exposure Report according to IEC 62479:2010
RF SPECTRUM AND EMC (articles 3.1b and 3.2):
1) ETSI EN 301 489-1 V2.2.3 (2019-11): Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 1
2) Draft ETSI EN 301 489-17 V3.2.2 (2019-12): Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 17
3) RED directive: RF Testing: ETSI EN 300 328 v 2.2.2 (2019): Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band, article 3.2 of Directive 2014/53/EU
RoHS COMPLIANCE:
1) EU RoHS: European Union Directive 2011/65/EU (RoHS 2) Annex II + Amendment Directive 2015/863/EU (RoHS 3). Lead present in copper alloy (brass) internal mechanical components is exempt under Annex III, Exemption 6(c) (lead in copper alloy up to 4% by weight).
Signed for and on behalf of: ActivBody Inc.:
Jonathan Tait, CEO
March 16, 2026