Tremitas Tremipen, Instructions For Use Manual

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15. Reference to Clinical Performance
16. Allowed Languages for this IfU
A Clinical Evaluation for the Clinical Performance is
available for the Tremipen®.
For more information about these documents, which
are part of the product development file, please contact
the Tremitas GmbH or your local Tremipen® distributor.
Regarding the allowed languages, national laws
relating to the “Medical Devices Directive 93/42/EEC –
Part: Mandatory Language Requirements for Medical
Devices“, apply.
This IfU is available in the following reference
languages (Feb. 03rd 2020):
- GERMAN
- ENGLISH
Further and new languages will be announced on:
www.tremitas.com.
14. Information about Safety Reports
A safety report and a safety and risk analysis are
available for the Tremipen®. For more information
about these documents, which are part of the product
development file, please contact the Tremitas GmbH or
your local Tremipen® distributor.
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Tremipen® is NOT A STERILE medical device!
Tremipen® is NOT intended for single use!
Tremipen® is NOT a custom made product!
12. Definition of Color Coding and
Identifying Colors
13. Special Exclusions
No special identifying colors or color codings are used
for the Tremipen®.