13 Compliance
13.1 Environmental Practices
LumiraDx complies with all environmental legislation in each country where the product
is sold. Please refer to lumiradx.com for further information.
13.2 Compliance
LumiraDx UK Ltd hereby declares that the product complies with all relevant European
Directives and Regulations at the time of placing on the market. The EC Declaration of
Conformity may be found at lumiradx.com. The LumiraDx Instrument has been tested
and is compliant with:
CAN/CSA-C22.2 No. 61010-1-12 - Safety requirements for electrical equipment for
measurement, control and laboratory use – Part 1: General requirements.
CAN/CSA-C22.2 No. 61010-2-101:15 - Safety requirements for electrical equipment for
measurement, control, and laboratory use – Part 2-101: Particular requirements for in vitro
diagnostic (IVD) medical equipment.
UL 61010-1 (Third Edition) - Safety requirements for electrical equipment for
measurement, control and laboratory use – Part 1: General requirements.
UL 61010-2-101 (Second Edition) - Safety requirements for electrical equipment for
measurement, control, and laboratory use – Part 2-101: Particular requirements for in vitro
diagnostic (IVD) medical equipment.
ANATEL – Brazil. This equipment is not entitled to protection against harmful interference
and cannot cause interference in duly authorized systems. For more information, access
the ANATEL website at www.anatel.gov.br. It incorporates a product approved by Anatel
under number (18178-20-13558 and 18181-20-13528) referring to the models OEM-DES-
M900-LUM and LDXWS 00946_2.
Compliance - 97
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