Regulatory
approval type Description
· IEC 61010-2-101, "Safety Requirements for
Electrical Equipment for Measurement, Control and
Laboratory Use - Part 2-101: Particular Require-
ments for In Vitro Diagnostic (IVD) Medical
Equipment".
CB Report
CB Certificate
A CB report
and
certificate have been
issued for this
product. A copy of the certificate is available upon
request.
U.S. FDA Listing The osmometer, along with the calibrators and controls
manufactured by Advanced Instruments, are listed with
a U.S. Department of Health and Human Services,
Food and Drug Administration, as:
Osmometer Class 1
Calibrators
Class 1
Controls Class 1
Health Canada The osmometer, along with the calibrators and controls
License manufactured by Advanced Instruments, are licensed
with Health Canada, Therapeutic Products Directorate,
Medical Devices Bureau, as:
Osmometer Class 2
Calibrators Class 2
Controls Class 2
EC Declaration of
Conformity - IVD
This product meets the intent of Directive 98/79/EC
for In Vitro Diagnostic Medical Devices. Consult the
Declaration of Conformity certificate shipped with
the product (if required)
for the latest update.
(continued)
Regulatory Notices
111
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